82_FR_41438 82 FR 41271 - Determination of Regulatory Review Period for Purposes of Patent Extension; XTORO

82 FR 41271 - Determination of Regulatory Review Period for Purposes of Patent Extension; XTORO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 167 (August 30, 2017)

Page Range41271-41273
FR Document2017-18379

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XTORO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Federal Register, Volume 82 Issue 167 (Wednesday, August 30, 2017) 
[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41271-41273]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18379]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0624]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; XTORO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for XTORO and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Director of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
product.

DATES: Anyone with knowledge that any of the dates as published (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by October 
30, 2017. Furthermore, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period by February 26, 2018. 
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

[[Page 41272]]


ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 30, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 30, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-E-0624 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; XTORO.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff Office between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff Office. If you do 
not wish your name and contact information to be made publicly 
available, you can provide this information on the cover sheet and not 
in the body of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term 
Restoration Act (Pub. L. 100-670) generally provide that a patent may 
be extended for a period of up to 5 years so long as the patented item 
(human drug product, animal drug product, medical device, food 
additive, or color additive) was subject to regulatory review by FDA 
before the item was marketed. Under these acts, a product's regulatory 
review period forms the basis for determining the amount of extension 
an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug product. 
Although only a portion of a regulatory review period may count toward 
the actual amount of extension that the Director of USPTO may award 
(for example, half the testing phase must be subtracted as well as any 
time that may have occurred before the patent was issued), FDA's 
determination of the length of a regulatory review period for a human 
drug product will include all of the testing phase and approval phase 
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product XTORO 
(finafloxacin). XTORO is indicated for treatment of acute otitis 
externa caused by susceptible strains of Pseudomonas aeruginosa and 
Staphylococcus aureus. Subsequent to this approval, the USPTO received 
a patent term restoration application for XTORO (U.S. Patent No. 
6,133,260) from Alcon Pharmaceutials Ltd. for Bayer Intellectual 
Property GmbH, and the USPTO requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated May 2, 2016, FDA advised the USPTO that this human drug product 
had undergone a regulatory review period and that the approval of XTORO 
represented the first permitted commercial marketing or use of the 
product. Thereafter, the USPTO requested that FDA determine the 
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for 
XTORO is 1,880 days. Of this time, 1,643 days occurred during the 
testing phase of the regulatory review period, while 237 days occurred 
during the

[[Page 41273]]

approval phase. These periods of time were derived from the following 
dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: October 26, 2009. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on October 26, 2009.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: April 25, 
2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for XTORO (NDA 206307) was initially submitted on 
April 25, 2014.
    3. The date the application was approved: December 17, 2014. FDA 
has verified the applicant's claim that NDA 206307 was approved on 
December 17, 2014.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 1,058 days of patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit either electronic or written comments and, under 
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as 
specified in 21 CFR 60.30, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period. To meet its burden, 
the petition must comply with all the requirements of 21 CFR 60.30, 
including but not limited to: Must be timely (see DATES), must be filed 
in accordance with 21 CFR 10.20, must contain sufficient facts to merit 
an FDA investigation, and must certify that a true and complete copy of 
the petition has been served upon the patent applicant. (See H. Rept. 
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should 
be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at 
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are 
required) to the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18379 Filed 8-29-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41271 • Mail/Hand delivery/Courier (for Staff office, 5630 Fishers Lane, Rm. This draft revised guidance is being written/paper submissions): Dockets 1061, Rockville, MD 20852. issued consistent with FDA’s good Management Staff (HFA–305), Food and Submit written requests for single guidance practices regulation (21 CFR Drug Administration, 5630 Fishers copies of the draft revised guidance to 10.115). The draft revised guidance, Lane, Rm. 1061, Rockville, MD 20852. the Division of Drug Information, Center when finalized, will represent the • For written/paper comments for Drug Evaluation and Research, Food current thinking of FDA on the design submitted to the Dockets Management and Drug Administration, 10001 New of BE studies to support ANDAs for Staff, FDA will post your comment, as Hampshire Ave., Hillandale Building, digoxin tablets. It does not establish any well as any attachments, except for 4th Floor, Silver Spring, MD 20993– rights for any person and is not binding information submitted, marked and 0002. Send one self-addressed adhesive on FDA or the public. You can use an identified, as confidential, if submitted label to assist that office in processing alternative approach if it satisfies the as detailed in ‘‘Instructions.’’ your requests. See the SUPPLEMENTARY requirements of the applicable statutes Instructions: All submissions received INFORMATION section for electronic and regulations. must include the Docket No. FDA– access to the draft revised guidance II. Electronic Access 2007–D–0369 for ‘‘Draft Guidance on document. Digoxin.’’ Received comments will be Persons with access to the internet FOR FURTHER INFORMATION CONTACT: may obtain the draft revised guidance at placed in the docket and, except for Xiaoqiu Tang, Center for Drug either https://www.fda.gov/Drugs/ those submitted as ‘‘Confidential Evaluation and Research, Food and GuidanceComplianceRegulatory Submissions,’’ will be publicly viewable Drug Administration, 10903 New Information/Guidances/default.htm or at https://www.regulations.gov or at the Hampshire Ave., Bldg. 75, Rm. 4730, https://www.regulations.gov. Dockets Management Staff office Silver Spring, MD 20993–0002, 301– Dated: August 24, 2017. between 9 a.m. and 4 p.m., Monday 796–5850. Anna K. Abram, through Friday. • Confidential Submissions—To SUPPLEMENTARY INFORMATION: Deputy Commissioner for Policy, Planning, submit a comment with confidential Legislation, and Analysis. I. Background information that you do not wish to be [FR Doc. 2017–18386 Filed 8–29–17; 8:45 am] made publicly available, submit your In the Federal Register of June 11, BILLING CODE 4164–01–P comments only as a written/paper 2010 (75 FR 33311), FDA announced the submission. You should submit two availability of a guidance for industry copies total. One copy will include the entitled ‘‘Bioequivalence DEPARTMENT OF HEALTH AND information you claim to be confidential Recommendations for Specific HUMAN SERVICES with a heading or cover note that states Products,’’ which explained the process ‘‘THIS DOCUMENT CONTAINS that would be used to make product- Food and Drug Administration CONFIDENTIAL INFORMATION.’’ The specific guidances available to the [Docket No. FDA–2016–E–0624] Agency will review this copy, including public on FDA’s Web site at https:// the claimed confidential information, in www.fda.gov/Drugs/ Determination of Regulatory Review its consideration of comments. The GuidanceCompliance Period for Purposes of Patent second copy, which will have the RegulatoryInformation/Guidances/ Extension; XTORO claimed confidential information default.htm. AGENCY: Food and Drug Administration, redacted/blacked out, will be available As described in that guidance, FDA HHS. for public viewing and posted on adopted this process to develop and disseminate product-specific guidances ACTION: Notice. https://www.regulations.gov. Submit both copies to the Dockets Management and to provide a meaningful SUMMARY: The Food and Drug Staff. If you do not wish your name and opportunity for the public to consider Administration (FDA or the Agency) has contact information to be made publicly and comment on the guidances. This determined the regulatory review period available, you can provide this notice announces the availability of a for XTORO and is publishing this notice information on the cover sheet and not draft revised product-specific guidance of that determination as required by in the body of your comments and you for generic digoxin tablets. law. FDA has made the determination must identify this information as FDA initially approved new drug because of the submission of an ‘‘confidential.’’ Any information marked application (NDA) 020405 for LANOXIN application to the Director of the U.S. as ‘‘confidential’’ will not be disclosed (digoxin tablets) in September 1997. In Patent and Trademark Office (USPTO), except in accordance with 21 CFR 10.20 May 2008, we issued a final guidance Department of Commerce, for the and other applicable disclosure law. For for industry on generic digoxin tablets. extension of a patent which claims that more information about FDA’s posting We are now issuing a draft revised human drug product. of comments to public dockets, see 80 guidance for industry on generic DATES: Anyone with knowledge that any FR 56469, September 18, 2015, or access digoxin tablets (‘‘Draft Guidance on of the dates as published (in the the information at: https://www.gpo.gov/ Digoxin’’). SUPPLEMENTARY INFORMATION section) are fdsys/pkg/FR-2015-09-18/pdf/2015- In December 2015, Concordia incorrect may submit either electronic 23389.pdf. Pharmaceuticals submitted a citizen or written comments and ask for a Docket: For access to the docket to petition requesting, among other things, redetermination by October 30, 2017. read background documents or the that FDA amend the guidance for Furthermore, any interested person may mstockstill on DSK30JT082PROD with NOTICES electronic and written/paper comments industry on BE recommendations for petition FDA for a determination received, go to https:// generic digoxin tablets issued in 2008. regarding whether the applicant for www.regulations.gov and insert the FDA has reviewed the issues raised in extension acted with due diligence docket number, found in brackets in the the citizen petition and is responding to during the regulatory review period by heading of this document, into the the citizen petition (Docket No. FDA– February 26, 2018. See ‘‘Petitions’’ in ‘‘Search’’ box and follow the prompts 2015–P–4566, available at https:// the SUPPLEMENTARY INFORMATION section and/or go to the Dockets Management www.regulations.gov). for more information. VerDate Sep<11>2014 17:40 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1

41272 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices ADDRESSES: You may submit comments manner (see ADDRESSES), will be placed Animal Drug and Patent Term as follows. Please note that late, in the docket and, except for those Restoration Act (Pub. L. 100–670) untimely filed comments will not be submitted as ‘‘Confidential generally provide that a patent may be considered. Electronic comments must Submissions,’’ publicly viewable at extended for a period of up to 5 years be submitted on or before October 30, https://www.regulations.gov or at the so long as the patented item (human 2017. The https://www.regulations.gov Dockets Management Staff Office drug product, animal drug product, electronic filing system will accept between 9 a.m. and 4 p.m., Monday medical device, food additive, or color comments until midnight Eastern Time through Friday. additive) was subject to regulatory at the end of October 30, 2017. • Confidential Submissions—To review by FDA before the item was Comments received by mail/hand submit a comment with confidential marketed. Under these acts, a product’s delivery/courier (for written/paper information that you do not wish to be regulatory review period forms the basis submissions) will be considered timely made publicly available, submit your for determining the amount of extension if they are postmarked or the delivery comments only as a written/paper an applicant may receive. service acceptance receipt is on or submission. You should submit two A regulatory review period consists of before that date. copies total. One copy will include the two periods of time: A testing phase and information you claim to be confidential an approval phase. For human drug Electronic Submissions products, the testing phase begins when with a heading or cover note that states Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical following way: CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes • Federal eRulemaking Portal: Agency will review this copy, including effective and runs until the approval https://www.regulations.gov. Follow the the claimed confidential information, in phase begins. The approval phase starts instructions for submitting comments. its consideration of comments. The with the initial submission of an Comments submitted electronically, second copy, which will have the application to market the human drug including attachments, to https:// claimed confidential information product and continues until FDA grants www.regulations.gov will be posted to redacted/blacked out, will be available permission to market the drug product. the docket unchanged. Because your for public viewing and posted on Although only a portion of a regulatory comment will be made public, you are https://www.regulations.gov. Submit review period may count toward the solely responsible for ensuring that your both copies to the Dockets Management actual amount of extension that the comment does not include any Staff Office. If you do not wish your Director of USPTO may award (for confidential information that you or a name and contact information to be example, half the testing phase must be third party may not wish to be posted, made publicly available, you can subtracted as well as any time that may such as medical information, your or provide this information on the cover have occurred before the patent was anyone else’s Social Security number, or sheet and not in the body of your issued), FDA’s determination of the confidential business information, such comments and you must identify this length of a regulatory review period for as a manufacturing process. Please note information as ‘‘confidential.’’ Any a human drug product will include all that if you include your name, contact information marked as ‘‘confidential’’ of the testing phase and approval phase information, or other information that will not be disclosed except in as specified in 35 U.S.C. 156(g)(1)(B). identifies you in the body of your FDA has approved for marketing the accordance with 21 CFR 10.20 and other comments, that information will be human drug product XTORO applicable disclosure law. For more posted on https://www.regulations.gov. (finafloxacin). XTORO is indicated for information about FDA’s posting of • If you want to submit a comment comments to public dockets, see 80 FR treatment of acute otitis externa caused with confidential information that you by susceptible strains of Pseudomonas 56469, September 18, 2015, or access do not wish to be made available to the aeruginosa and Staphylococcus aureus. the information at: https://www.gpo.gov/ public, submit the comment as a Subsequent to this approval, the USPTO fdsys/pkg/FR-2015-09-18/pdf/2015- received a patent term restoration written/paper submission and in the 23389.pdf. manner detailed (see ‘‘Written/Paper application for XTORO (U.S. Patent No. Docket: For access to the docket to 6,133,260) from Alcon Pharmaceutials Submissions’’ and ‘‘Instructions’’). read background documents or the Ltd. for Bayer Intellectual Property Written/Paper Submissions electronic and written/paper comments GmbH, and the USPTO requested FDA’s received, go to https:// assistance in determining this patent’s Submit written/paper submissions as www.regulations.gov and insert the eligibility for patent term restoration. In follows: • Mail/Hand delivery/Courier (for docket number, found in brackets in the a letter dated May 2, 2016, FDA advised written/paper submissions): Dockets heading of this document, into the the USPTO that this human drug Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts product had undergone a regulatory Drug Administration, 5630 Fishers and/or go to the Dockets Management review period and that the approval of Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061, XTORO represented the first permitted • For written/paper comments Rockville, MD 20852. commercial marketing or use of the submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT: product. Thereafter, the USPTO Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory requested that FDA determine the well as any attachments, except for Policy, Food and Drug Administration, product’s regulatory review period. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51, identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993, II. Determination of Regulatory Review mstockstill on DSK30JT082PROD with NOTICES as detailed in ‘‘Instructions.’’ 301–796–3600. Period Instructions: All submissions received SUPPLEMENTARY INFORMATION: FDA has determined that the must include the Docket No. FDA– applicable regulatory review period for 2016–E–0624 for ‘‘Determination of I. Background XTORO is 1,880 days. Of this time, Regulatory Review Period for Purposes The Drug Price Competition and 1,643 days occurred during the testing of Patent Extension; XTORO.’’ Received Patent Term Restoration Act of 1984 phase of the regulatory review period, comments, those filed in a timely (Pub. L. 98–417) and the Generic while 237 days occurred during the VerDate Sep<11>2014 17:40 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41273 approval phase. These periods of time Dated: August 24, 2017. supplement ANDA 078311 in paper were derived from the following dates: Anna K. Abram, format on August 29, 2013, and in 1. The date an exemption under Deputy Commissioner for Policy, Planning, electronic format on May 9, 2014. Legislation, and Analysis. On April 14, 2016, FDA informed section 505(i) of the Federal Food, Drug, [FR Doc. 2017–18379 Filed 8–29–17; 8:45 am] Upsher-Smith that the applicant’s fed and Cosmetic Act (the FD&C Act) (21 bioequivalence study failed to meet U.S.C. 355(i)) became effective: October BILLING CODE 4164–01–P FDA’s bioequivalence criteria and, 26, 2009. FDA has verified the therefore, requested that Upsher-Smith applicant’s claim that the date the voluntarily seek withdrawal of ANDA DEPARTMENT OF HEALTH AND investigational new drug application 078311 under § 314.150(d) (21 CFR HUMAN SERVICES became effective was on October 26, 314.150(d)). 2009. Food and Drug Administration In a letter dated May 13, 2016, 2. The date the application was Upsher-Smith requested that FDA [Docket No. FDA–2017–N–0002] initially submitted with respect to the withdraw approval of ANDA 078311 for human drug product under section Upsher-Smith Laboratories, Inc.; PROPRANOLOL HYDROCHLORIDE 505(b) of the FD&C Act: April 25, 2014. Withdrawal of Approval of an Extended-Release Capsules under FDA has verified the applicant’s claim Abbreviated New Drug Application for § 314.150(d) because the new that the new drug application (NDA) for PROPRANOLOL HYDROCHLORIDE bioequivalence data did not XTORO (NDA 206307) was initially demonstrate therapeutic equivalence of submitted on April 25, 2014. AGENCY: Food and Drug Administration, its product to the RLD, INDERAL LA. In HHS. that letter, Upsher-Smith also waived 3. The date the application was any opportunity for a hearing otherwise ACTION: Notice. approved: December 17, 2014. FDA has provided under § 314.150(a). verified the applicant’s claim that NDA SUMMARY: The Food and Drug Therefore, under section 505(e) of the 206307 was approved on December 17, Administration (FDA or the Agency) is Federal Food, Drug, and Cosmetic Act 2014. withdrawing approval of an abbreviated (FD&C Act) (21 U.S.C. 355(e)) and This determination of the regulatory new drug application (ANDA) for § 314.150(d), and under authority review period establishes the maximum PROPRANOLOL HYDROCHLORIDE delegated by the Commissioner of Food potential length of a patent extension. Extended-Release Capsules, held by and Drugs to the Director, Center for However, the USPTO applies several Upsher-Smith Laboratories, Inc. Drug Evaluation and Research, approval statutory limitations in its calculations (Upsher-Smith), 6701 Evenstad Dr., of ANDA 078311, and all amendments of the actual period for patent extension. Maple Grove, MN 55369. Upsher-Smith and supplements thereto, is withdrawn In its application for patent extension, has voluntarily requested that approval (see DATES). Distribution of this product this applicant seeks 1,058 days of patent of this application be withdrawn and in interstate commerce without an term extension. has waived its opportunity for a hearing. approved application is illegal and DATES: August 30, 2017. subject to regulatory action (see sections Anyone with knowledge that any of 505(a) and 301(d) of the FD&C Act (21 the dates as published are incorrect may FOR FURTHER INFORMATION CONTACT: Stefanie Kraus, Center for Drug U.S.C. 355(a) and 331(d)). submit either electronic or written Evaluation and Research, Food and Dated: August 24, 2017. comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Drug Administration, 10903 New Anna K. Abram, Furthermore, as specified in 21 CFR Hampshire Ave., Bldg. 51, Rm. 6215, Deputy Commissioner for Policy, Planning, 60.30, any interested person may Silver Spring, MD 20993–0002, 301– Legislation, and Analysis. petition FDA for a determination 796–9585. [FR Doc. 2017–18375 Filed 8–29–17; 8:45 am] regarding whether the applicant for SUPPLEMENTARY INFORMATION: On March BILLING CODE 4164–01–P extension acted with due diligence 6, 2009, FDA approved abbreviated new during the regulatory review period. To drug application (ANDA) 078311 for PROPRANOLOL HYDROCHLORIDE DEPARTMENT OF HEALTH AND meet its burden, the petition must HUMAN SERVICES comply with all the requirements of 21 Extended-Release Capsules, USP, 60 CFR 60.30, including but not limited to: milligrams (mg), 80 mg, 120 mg, and Food and Drug Administration Must be timely (see DATES), must be 160 mg. In a letter dated August 9, 2011, filed in accordance with 21 CFR 10.20, FDA informed Upsher-Smith that it had [Docket No. FDA–2017–P–1461] must contain sufficient facts to merit an concerns about the validity of bioequivalence data submitted with Determination That CENESTIN FDA investigation, and must certify that (Estrogens, Conjugated Synthetic A) a true and complete copy of the petition ANDA 078311 from studies conducted by a certain contract research Tablets, 0.3 Milligrams, 0.45 Milligrams, has been served upon the patent 0.625 Milligrams, 0.9 Milligrams, and organization, establishing applicant. (See H. Rept. 857, part 1, 98th 1.25 Milligrams, Were Not Withdrawn bioequivalence of Upsher-Smith’s Cong., 2d sess., pp. 41–42, 1984.) From Sale for Reasons of Safety or product to the reference listed drug Petitions should be in the format Effectiveness (RLD), INDERAL LA (propranolol specified in 21 CFR 10.30. hydrochloride) Extended Release AGENCY: Food and Drug Administration, Submit petitions electronically to Capsules, 60 mg, 80 mg, 120 mg, and mstockstill on DSK30JT082PROD with NOTICES HHS. https://www.regulations.gov at Docket 160 mg. In that letter, FDA directed ACTION: Notice. No. FDA–2013–S–0610. Submit written Upsher-Smith to supplement its ANDA petitions (two copies are required) to the with either: (1) New bioequivalence SUMMARY: The Food and Drug Dockets Management Staff (HFA–305), studies or (2) re-assays of the samples Administration (FDA or Agency) has Food and Drug Administration, 5630 from the original bioequivalence determined that CENESTIN (estrogens, Fishers Lane, Rm. 1061, Rockville, MD studies. Upsher-Smith submitted new conjugated synthetic A) Tablets, 0.3 20852. fasted and fed bioequivalence studies to milligrams (mg), 0.45 mg, 0.625 mg, 0.9 VerDate Sep<11>2014 17:40 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1


Document Created: 2017-08-30 04:08:45
Document Modified: 2017-08-30 04:08:45
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by October 30, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by February 26, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation82 FR 41271 
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