83 FR 2455 - Delcor Asset Corp. et al.; Withdrawal of Approval of 22 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 11 (January 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 11 (January 17, 2018)
| Page Range | 2455-2456 | |
| FR Document | 2018-00695 |
[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)] [Notices] [Pages 2455-2456] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00695] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0002] Delcor Asset Corp. et al.; Withdrawal of Approval of 22 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 22 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of February 16, 2018. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, [email protected]. SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling. Table 1--ANDAs for Which FDA Is Withdrawing Approval ---------------------------------------------------------------------------------------------------------------- Application No. Drug Applicant ---------------------------------------------------------------------------------------------------------------- ANDA 060577........................ Mycostatin (nystatin) Vaginal Delcor Asset Corp., 411 South State Tablets, 100,000 units. St., Suite E-100, Newtown, PA 18940. ANDA 063302........................ Cefamandole Nafate for Injection..... ACS Dobfar SpA, c/o Interchem Corp., 120 Route 17 North, Paramus, NJ 07653. ANDA 070462........................ Diazepam Tablets USP, 2 milligrams Virtus Pharmaceuticals, 12 Penns (mg). Trail, Newtown, PA 18940. ANDA 070463........................ Diazepam Tablets USP, 5 mg........... Do. ANDA 070998........................ Potassium Chloride Extended-Release Future Pak, Ltd., 28115 Lakeview Tablets, 8 milliequivalents (mEq). Dr., Wixom, MI 48393. ANDA 070999........................ Potassium Chloride Extended-Release Do. Tablets, 10 mEq. [[Page 2456]] ANDA 075375........................ Diltiazem Hydrochloride (HCl) Mylan Laboratories, Ltd., c/o Mylan Injection, 5 mg/milliliter (mL). Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. ANDA 076911........................ Clorazepate Dipotassium Tablets USP, Sun Pharmaceutical Industries, Ltd., 3.75 mg, 7.5 mg, and 15 mg. c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. ANDA 077102........................ Calcitriol Injection, 0.001 mg/mL.... Sagent Pharmaceuticals, Inc., 1901 N. Roselle Rd., Suite 450, Schaumburg, IL 60195. ANDA 084656........................ Acetaminophen and Codeine Phosphate Roxane Laboratories, Inc., 1809 Tablets USP, 300 mg/30 mg. Wilson Rd., Columbus, OH 43228. ANDA 087977........................ Diphenhydramine HCl Capsules, 25 mg.. LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY 11788. ANDA 088676........................ Methylprednisolone Sodium Succinate LyphoMed, Division of Fujisawa USA, for Injection USP, Equivalent to 40 Inc., 2045 North Cornell Ave., mg base/vial. Melrose Park, IL 60160. ANDA 089080........................ Acetaminophen and Codeine Phosphate Purepac Pharmaceutical Co., 200 Tablets USP, 300 mg/30 mg. Elmora Ave., Elizabeth, NJ 07207. ANDA 089183........................ Acetaminophen and Codeine Phosphate Superpharm Corp., 1769 Fifth Ave., Tablets USP, 300 mg/15 mg. Bayshore, NY 11706. ANDA 089253........................ Acetaminophen and Codeine Phosphate Do. Tablets USP, 300 mg/30 mg. ANDA 089219........................ Procainamide HCl Capsules USP, 250 IDT Australia, Ltd., c/o Facet Life mg, 375 mg, and 500 mg. Sciences, Inc., 6122 Stone Wolfe Dr., Glen Carbon, IL 62034. ANDA 089254........................ Acetaminophen and Codeine Phosphate Do. Tablets USP, 300 mg/60 mg. ANDA 089369........................ Procainamide HCl Extended-Release Do. Tablets USP, 250 mg, 500 mg, and 750 mg. ANDA 089481........................ Acetaminophen and Codeine Phosphate American Therapeutics, Inc., 75 Tablets USP, 300 mg/15 mg. Carlough Rd., Bohemia, NY 11716. ANDA 089482........................ Acetaminophen and Codeine Phosphate Do. Tablets USP, 300 mg/30 mg. ANDA 089483........................ Acetaminophen and Codeine Phosphate Do. Tablets USP, 300 mg/60 mg. ANDA 206711........................ Olanzapine Tablets USP, 2.5 mg, 5 mg, Ajanta Pharma, Ltd., c/o Ajanta 7.5 mg, 10 mg, 15 mg, and 20 mg. Pharma USA, Inc., One Grande Commons, 440 U.S. Highway 22 East, Suite 150, Bridgewater, NJ 08807. ---------------------------------------------------------------------------------------------------------------- Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of February 16, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: January 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00695 Filed 1-16-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2455
actual amount of extension that the Act: March 31, 2014. FDA has verified the Dated: January 11, 2018.
Director of USPTO may award (for applicant’s claim that the new drug Leslie Kux,
example, half the testing phase must be application (NDA) for DAKLINZA (NDA Associate Commissioner for Policy.
subtracted as well as any time that may 206843) was initially submitted on March 31, [FR Doc. 2018–00675 Filed 1–16–18; 8:45 am]
have occurred before the patent was 2014.
BILLING CODE 4164–01–P
issued), FDA’s determination of the 3. The date the application was approved:
length of a regulatory review period for July 24, 2015. FDA has verified the
a human drug product will include all applicant’s claim that NDA 206843 was DEPARTMENT OF HEALTH AND
of the testing phase and approval phase approved on July 24, 2015. HUMAN SERVICES
as specified in 35 U.S.C. 156(g)(1)(B).
This determination of the regulatory
FDA has approved for marketing the Food and Drug Administration
human drug product DAKLINZA review period establishes the maximum
(daclatasvir dihydrochloride). potential length of a patent extension. [Docket No. FDA–2017–N–0002]
DAKLINZA is indicated for use with However, the USPTO applies several
statutory limitations in its calculations Delcor Asset Corp. et al.; Withdrawal
sofosbuvir for the treatment of chronic of Approval of 22 Abbreviated New
HCV genotype 3 infection. Subsequent of the actual period for patent extension.
In its application for patent extension, Drug Applications
to this approval, the USPTO received a
patent term restoration application for this applicant seeks 467 days of patent AGENCY: Food and Drug Administration,
DAKLINZA (U.S. Patent No. 8,329,159) term extension. HHS.
from Bristol-Myers Squibb Company, III. Petitions ACTION: Notice.
and the USPTO requested FDA’s
assistance in determining this patent’s Anyone with knowledge that any of SUMMARY: The Food and Drug
eligibility for patent term restoration. In the dates as published are incorrect may Administration (FDA or Agency) is
a letter dated July 12, 2016, FDA submit either electronic or written withdrawing approval of 22 abbreviated
advised the USPTO that this human comments and, under 21 CFR 60.24, ask new drug applications (ANDAs) from
drug product had undergone a for a redetermination (see DATES). multiple applicants. The holders of the
regulatory review period and that the Furthermore, as specified in § 60.30 (21 applications notified the Agency in
approval of DAKLINZA represented the CFR 60.30), any interested person may writing that the drug products were no
first permitted commercial marketing or longer marketed and requested that the
petition FDA for a determination
use of the product. Thereafter, the approval of the applications be
regarding whether the applicant for
USPTO requested that FDA determine withdrawn.
extension acted with due diligence
the product’s regulatory review period. DATES: Approval is withdrawn as of
during the regulatory review period. To
II. Determination of Regulatory Review meet its burden, the petition must February 16, 2018.
Period comply with all the requirements of FOR FURTHER INFORMATION CONTACT:
FDA has determined that the § 60.30, including but not limited to: Trang Tran, Center for Drug Evaluation
applicable regulatory review period for Must be timely (see DATES), must be and Research, Food and Drug
DAKLINZA is 2,808 days. Of this time, filed in accordance with § 10.20, must Administration, 10903 New Hampshire
2,327 days occurred during the testing contain sufficient facts to merit an FDA Ave., Bldg. 75, Rm. 1671, Silver Spring,
phase of the regulatory review period, investigation, and must certify that a MD 20993–0002, 240–402–7945,
while 481 days occurred during the true and complete copy of the petition Trang.Tran@fda.hhs.gov.
approval phase. These periods of time has been served upon the patent SUPPLEMENTARY INFORMATION: The
were derived from the following dates: applicant. (See H. Rept. 857, part 1, 98th holders of the applications listed in
1. The date an exemption under section Cong., 2d sess., pp. 41–42, 1984.) table 1 have informed FDA that these
505(i) of the Federal Food, Drug, and Petitions should be in the format drug products are no longer marketed
Cosmetic Act (the FD&C Act) (21 U.S.C. specified in 21 CFR 10.30. and have requested that FDA withdraw
355(i)) became effective: November 17, 2007. approval of the applications under the
The applicant claims November 16, 2007, as Submit petitions electronically to process in § 314.150(c) (21 CFR
the date the investigational new drug https://www.regulations.gov at Docket 314.150(c)). The applicants have also,
application (IND) became effective. However, No. FDA–2013–S–0610. Submit written by their requests, waived their
FDA records indicate that the IND effective petitions (two copies are required) to the
date was November 17, 2007, which was 30
opportunity for a hearing. Withdrawal
Dockets Management Staff (HFA–305), of approval of an application or
days after FDA receipt of the IND.
2. The date the application was initially Food and Drug Administration, 5630 abbreviated application under
submitted with respect to the human drug Fishers Lane, Rm. 1061, Rockville, MD § 314.150(c) is without prejudice to
product under section 505(b) of the FD&C 20852. refiling.
TABLE 1—ANDAS FOR WHICH FDA IS WITHDRAWING APPROVAL
Application No. Drug Applicant
ANDA 060577 .......... Mycostatin (nystatin) Vaginal Tablets, 100,000 units ........... Delcor Asset Corp., 411 South State St., Suite E–100,
Newtown, PA 18940.
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ANDA 063302 .......... Cefamandole Nafate for Injection ......................................... ACS Dobfar SpA, c/o Interchem Corp., 120 Route 17
North, Paramus, NJ 07653.
ANDA 070462 .......... Diazepam Tablets USP, 2 milligrams (mg) .......................... Virtus Pharmaceuticals, 12 Penns Trail, Newtown, PA
18940.
ANDA 070463 .......... Diazepam Tablets USP, 5 mg .............................................. Do.
ANDA 070998 .......... Potassium Chloride Extended-Release Tablets, 8 milli- Future Pak, Ltd., 28115 Lakeview Dr., Wixom, MI 48393.
equivalents (mEq).
ANDA 070999 .......... Potassium Chloride Extended-Release Tablets, 10 mEq .... Do.
VerDate Sep<11>2014 17:14 Jan 16, 2018 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1](https://thefederalregister.org/doc/83_FR_2466/page/1.svg)
![2456 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices
TABLE 1—ANDAS FOR WHICH FDA IS WITHDRAWING APPROVAL—Continued
Application No. Drug Applicant
ANDA 075375 .......... Diltiazem Hydrochloride (HCl) Injection, 5 mg/milliliter (mL) Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown,
WV 26504.
ANDA 076911 .......... Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, Sun Pharmaceutical Industries, Ltd., c/o Sun Pharma-
and 15 mg. ceutical Industries, Inc., 2 Independence Way, Princeton,
NJ 08540.
ANDA 077102 .......... Calcitriol Injection, 0.001 mg/mL ........................................... Sagent Pharmaceuticals, Inc., 1901 N. Roselle Rd., Suite
450, Schaumburg, IL 60195.
ANDA 084656 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus,
mg/30 mg. OH 43228.
ANDA 087977 .......... Diphenhydramine HCl Capsules, 25 mg .............................. LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY
11788.
ANDA 088676 .......... Methylprednisolone Sodium Succinate for Injection USP, LyphoMed, Division of Fujisawa USA, Inc., 2045 North
Equivalent to 40 mg base/vial. Cornell Ave., Melrose Park, IL 60160.
ANDA 089080 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth,
mg/30 mg. NJ 07207.
ANDA 089183 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Superpharm Corp., 1769 Fifth Ave., Bayshore, NY 11706.
mg/15 mg.
ANDA 089253 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Do.
mg/30 mg.
ANDA 089219 .......... Procainamide HCl Capsules USP, 250 mg, 375 mg, and IDT Australia, Ltd., c/o Facet Life Sciences, Inc., 6122
500 mg. Stone Wolfe Dr., Glen Carbon, IL 62034.
ANDA 089254 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Do.
mg/60 mg.
ANDA 089369 .......... Procainamide HCl Extended-Release Tablets USP, 250 Do.
mg, 500 mg, and 750 mg.
ANDA 089481 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 American Therapeutics, Inc., 75 Carlough Rd., Bohemia,
mg/15 mg. NY 11716.
ANDA 089482 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Do.
mg/30 mg.
ANDA 089483 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Do.
mg/60 mg.
ANDA 206711 .......... Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 Ajanta Pharma, Ltd., c/o Ajanta Pharma USA, Inc., One
mg, and 20 mg. Grande Commons, 440 U.S. Highway 22 East, Suite
150, Bridgewater, NJ 08807.
Therefore, approval of the DEPARTMENT OF HEALTH AND collection provisions of our veterinary
applications listed in table 1, and all HUMAN SERVICES feed directive (VFD) regulation.
amendments and supplements thereto, DATES: Submit either electronic or
is hereby withdrawn as of February 16, Food and Drug Administration written comments on the collection of
2018. Introduction or delivery for information by March 19, 2018.
introduction into interstate commerce of [Docket No. FDA–2010–N–0155] ADDRESSES: You may submit comments
products without approved new drug as follows. Please note that late,
applications violates section 301(a) and Agency Information Collection
Activities; Proposed Collection; untimely filed comments will not be
(d) of the Federal Food, Drug, and considered. Electronic comments must
Cosmetic Act (21 U.S.C. 331(a) and (d)). Comment Request; Veterinary Feed
Directive be submitted on or before March 19,
Drug products that are listed in table 1 2018. The https://www.regulations.gov
that are in inventory on the date that AGENCY: Food and Drug Administration, electronic filing system will accept
this notice becomes effective (see the HHS. comments until midnight Eastern Time
DATES section) may continue to be ACTION: Notice. at the end of March 19, 2018. Comments
dispensed until the inventories have received by mail/hand delivery/courier
been depleted or the drug products have SUMMARY: The Food and Drug (for written/paper submissions) will be
reached their expiration dates or Administration (FDA, Agency or we) is considered timely if they are
otherwise become violative, whichever announcing an opportunity for public postmarked or the delivery service
occurs first. comment on the proposed collection of acceptance receipt is on or before that
certain information by the Agency. date.
Dated: January 11, 2018.
Under the Paperwork Reduction Act of
Leslie Kux, Electronic Submissions
1995 (PRA), Federal Agencies are
Associate Commissioner for Policy. required to publish notice in the Submit electronic comments in the
ethrower on DSK3G9T082PROD with NOTICES
[FR Doc. 2018–00695 Filed 1–16–18; 8:45 am] Federal Register concerning each following way:
BILLING CODE 4164–01–P proposed collection of information, • Federal eRulemaking Portal:
including each proposed extension of an https://www.regulations.gov. Follow the
existing collection of information, and instructions for submitting comments.
to allow 60 days for public comment in Comments submitted electronically,
response to the notice. This notice including attachments, to https://
solicits comments on the information www.regulations.gov will be posted to
VerDate Sep<11>2014 17:14 Jan 16, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1](https://thefederalregister.org/doc/83_FR_2466/page/2.svg)
Document Created: 2018-10-26 09:56:57
Document Modified: 2018-10-26 09:56:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Approval is withdrawn as of February 16, 2018. | |
| Contact | Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, [email protected] | |
| FR Citation | 83 FR 2455 |
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