82 FR 49032 - Determination That ELAVIL (Amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 203 (October 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 203 (October 23, 2017)
| Page Range | 49032-49033 | |
| FR Document | 2017-22892 |
[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)] [Notices] [Pages 49032-49033] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22892] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-3581] Determination That ELAVIL (Amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that ELAVIL (amitriptyline hydrochloride) oral tablets, 10 milligrams (mg), 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for amitriptyline hydrochloride oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an [[Page 49033]] ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ``listed drug,'' which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ``Approved Drug Products With Therapeutic Equivalence Evaluations,'' which is known generally as the ``Orange Book.'' Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. ELAVIL (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, are the subject of NDA 012703, held by AstraZeneca, and initially approved on April 7, 1961. ELAVIL is indicated for the relief of symptoms of depression. ELAVIL (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, are currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. In the Federal Register of June 16, 2006 (71 FR 34940), FDA announced that it was withdrawing approval of NDA 012703, effective June 16, 2006. Alembic Pharmaceuticals Limited submitted a citizen petition dated June 5, 2017 (Docket No. FDA-2017-P-3581), under 21 CFR 10.30, requesting that the Agency determine whether ELAVIL (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under Sec. 314.161 that ELAVIL (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that these products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ELAVIL (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list ELAVIL (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, in the ``Discontinued Drug Product List'' section of the Orange Book. The ``Discontinued Drug Product List'' delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to ELAVIL (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: October 17, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-22892 Filed 10-20-17; 8:45 am] BILLING CODE 4164-01-P
![49032 Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices
Rm. 6250, Silver Spring, MD 20993, commercial marketing or use of the investigation, and must certify that a
301–796–3600. product. Thereafter, the USPTO true and complete copy of the petition
SUPPLEMENTARY INFORMATION: requested that FDA determine the has been served upon the patent
product’s regulatory review period. applicant. (See H. Rept. 857, part 1, 98th
I. Background Cong., 2d sess., pp. 41–42, 1984.)
II. Determination of Regulatory Review
The Drug Price Competition and Petitions should be in the format
Period
Patent Term Restoration Act of 1984 specified in 21 CFR 10.30.
(Pub. L. 98–417) and the Generic FDA has determined that the Submit petitions electronically to
Animal Drug and Patent Term applicable regulatory review period for https://www.regulations.gov at Docket
Restoration Act (Pub. L. 100–670) OBIZUR is 4,216 days. Of this time, No. FDA–2013–S–0610. Submit written
generally provide that a patent may be 3,883 days occurred during the testing petitions (two copies are required) to the
extended for a period of up to 5 years phase of the regulatory review period, Dockets Management Staff (HFA–305),
so long as the patented item (human while 333 days occurred during the Food and Drug Administration, 5630
drug product, animal drug product, approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD
medical device, food additive, or color were derived from the following dates: 20852.
additive) was subject to regulatory 1. The date an exemption under
section 505(i) of the Federal Food, Drug, Dated: October 17, 2017.
review by FDA before the item was
and Cosmetic Act (21 U.S.C. 355(i)) Leslie Kux,
marketed. Under these acts, a product’s
regulatory review period forms the basis became effective: April 10, 2003. The Associate Commissioner for Policy.
for determining the amount of extension applicant claims May 27, 2003, as the [FR Doc. 2017–22898 Filed 10–20–17; 8:45 am]
an applicant may receive. date the investigational new drug BILLING CODE 4164–01–P
A regulatory review period consists of application (IND) became effective.
two periods of time: A testing phase and However, FDA records indicate that the
an approval phase. For human IND effective date was April 10, 2003. DEPARTMENT OF HEALTH AND
biological products, the testing phase 2. The date the application was HUMAN SERVICES
begins when the exemption to permit initially submitted with respect to the
the clinical investigations of the human biological product under section Food and Drug Administration
biological product becomes effective 351 of the Public Health Service Act (42 [Docket No. FDA–2017–P–3581]
and runs until the approval phase U.S.C. 262): November 25, 2013. The
begins. The approval phase starts with applicant claims October 10, 2013, as Determination That ELAVIL
the initial submission of an application the date the biologics license (Amitriptyline Hydrochloride) Oral
to market the human biological product application (BLA) for OBIZUR (BLA Tablets, 10, 25, 50, 75, 100, and 150
and continues until FDA grants 125512/0) was initially submitted. Milligrams, Were Not Withdrawn From
permission to market the biological However, FDA records indicate that Sale for Reasons of Safety or
product. Although only a portion of a BLA 125512/0 was submitted on Effectiveness
regulatory review period may count November 25, 2013.
3. The date the application was AGENCY: Food and Drug Administration,
toward the actual amount of extension
that the Director of USPTO may award approved: October 23, 2014. FDA has HHS.
(for example, half the testing phase must verified the applicant’s claim that BLA ACTION: Notice.
be subtracted as well as any time that 125512/0 was approved on October 23, SUMMARY: The Food and Drug
may have occurred before the patent 2014. Administration (FDA or Agency) has
was issued), FDA’s determination of the This determination of the regulatory
determined that ELAVIL (amitriptyline
length of a regulatory review period for review period establishes the maximum
hydrochloride) oral tablets, 10
a human biological product will include potential length of a patent extension.
milligrams (mg), 25 mg, 50 mg, 75 mg,
all of the testing phase and approval However, the USPTO applies several
100 mg, and 150 mg, were not
phase as specified in 35 U.S.C. statutory limitations in its calculations
withdrawn from sale for reasons of
156(g)(1)(B). of the actual period for patent extension.
safety or effectiveness. This
FDA has approved for marketing the In its applications for patent extension,
human biologic product OBIZUR determination will allow FDA to
this applicant seeks 5 years of patent
(rpFVIII). OBIZUR is indicated for the approve abbreviated new drug
term extension.
treatment of bleeding episodes in adults applications (ANDAs) for amitriptyline
with acquired hemophilia A. III. Petitions hydrochloride oral tablets, 10 mg, 25
Subsequent to this approval, the USPTO Anyone with knowledge that any of mg, 50 mg, 75 mg, 100 mg, and 150 mg,
received patent term restoration the dates as published are incorrect may if all other legal and regulatory
applications for OBIZUR (U.S. Patent submit either electronic or written requirements are met.
Nos. 6,180,371; 6,458,563; and comments and, under 21 CFR 60.24, ask FOR FURTHER INFORMATION CONTACT:
7,560,107) from Emory University and for a redetermination (see DATES). Stacy Kane, Center for Drug Evaluation
(U.S. Patent No. 7,576,181) from Emory Furthermore, as specified in § 60.30 (21 and Research, Food and Drug
University, Baxter International, Inc., CFR 60.30), any interested person may Administration, 10903 New Hampshire
and Baxter Healthcare SA; and the petition FDA for a determination Ave., Bldg. 51, Rm. 6236, Silver Spring,
USPTO requested FDA’s assistance in regarding whether the applicant for MD 20993–0002, 301–796–8363,
determining the patents’ eligibility for extension acted with due diligence stacy.kane@fda.hhs.gov.
ethrower on DSK3G9T082PROD with NOTICES
patent term restoration. In letters dated during the regulatory review period. To SUPPLEMENTARY INFORMATION: In 1984,
October 19, 2015, and January 11, 2016, meet its burden, the petition must Congress enacted the Drug Price
FDA advised the USPTO that this comply with all the requirements of Competition and Patent Term
human biological product had § 60.30, including but not limited to: Restoration Act of 1984 (Pub. L. 98–417)
undergone a regulatory review period Must be timely (see DATES), must be (the 1984 amendments), which
and that the approval of OBIZUR filed in accordance with § 10.20, must authorized the approval of duplicate
represented the first permitted contain sufficient facts to merit an FDA versions of drug products under an
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![Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49033
ANDA procedure. ANDA applicants based on the information we have at this we) is announcing the availability of a
must, with certain exceptions, show that time, FDA has determined under new draft guidance for industry on
the drug for which they are seeking § 314.161 that ELAVIL (amitriptyline generic methylphenidate hydrochloride
approval contains the same active hydrochloride) oral tablets, 10 mg, 25 oral extended-release tablets entitled
ingredient in the same strength and mg, 50 mg, 75 mg, 100 mg, and 150 mg, ‘‘Draft Guidance on Methylphenidate
dosage form as the ‘‘listed drug,’’ which were not withdrawn for reasons of Hydrochloride.’’ The new draft
is a version of the drug that was safety or effectiveness. The petitioner guidance, when finalized, will provide
previously approved. ANDA applicants has identified no data or other product-specific recommendations on,
do not have to repeat the extensive information suggesting that these among other things, the design of
clinical testing otherwise necessary to products were withdrawn for reasons of bioequivalence (BE) studies to support
gain approval of a new drug application safety or effectiveness. We have abbreviated new drug applications
(NDA). carefully reviewed our files for records (ANDAs) for methylphenidate
The 1984 amendments include what concerning the withdrawal of ELAVIL hydrochloride oral extended-release
is now section 505(j)(7) of the Federal (amitriptyline hydrochloride) oral tablets.
Food, Drug, and Cosmetic Act (21 U.S.C. tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100
355(j)(7)), which requires FDA to DATES: Submit either electronic or
mg, and 150 mg, from sale. We have also
publish a list of all approved drugs. written comments on the draft guidance
independently evaluated relevant
FDA publishes this list as part of the by December 22, 2017 to ensure that the
literature and data for possible
‘‘Approved Drug Products With postmarketing adverse events. We have Agency considers your comment on this
Therapeutic Equivalence Evaluations,’’ found no information that would draft guidance before it begins work on
which is known generally as the indicate that this drug product was the final version of the guidance.
‘‘Orange Book.’’ Under FDA regulations, withdrawn from sale for reasons of ADDRESSES: You may submit comments
drugs are removed from the list if the safety or effectiveness. on any guidance at any time as follows:
Agency withdraws or suspends Accordingly, the Agency will Electronic Submissions
approval of the drug’s NDA or ANDA continue to list ELAVIL (amitriptyline
for reasons of safety or effectiveness or hydrochloride) oral tablets, 10 mg, 25 Submit electronic comments in the
if FDA determines that the listed drug mg, 50 mg, 75 mg, 100 mg, and 150 mg, following way:
was withdrawn from sale for reasons of in the ‘‘Discontinued Drug Product List’’ • Federal eRulemaking Portal:
safety or effectiveness (21 CFR 314.162). section of the Orange Book. The https://www.regulations.gov. Follow the
A person may petition the Agency to ‘‘Discontinued Drug Product List’’ instructions for submitting comments.
determine, or the Agency may delineates, among other items, drug Comments submitted electronically,
determine on its own initiative, whether products that have been discontinued including attachments, to https://
a listed drug was withdrawn from sale from marketing for reasons other than www.regulations.gov will be posted to
for reasons of safety or effectiveness. safety or effectiveness. ANDAs that refer the docket unchanged. Because your
This determination may be made at any to ELAVIL (amitriptyline hydrochloride) comment will be made public, you are
time after the drug has been withdrawn oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, solely responsible for ensuring that your
from sale, but must be made prior to 100 mg, and 150 mg, may be approved comment does not include any
approving an ANDA that refers to the by the Agency as long as they meet all confidential information that you or a
listed drug (§ 314.161 (21 CFR 314.161)). other legal and regulatory requirements third party may not wish to be posted,
FDA may not approve an ANDA that for the approval of ANDAs. If FDA such as medical information, your or
does not refer to a listed drug. determines that labeling for this drug anyone else’s Social Security number, or
ELAVIL (amitriptyline hydrochloride) product should be revised to meet confidential business information, such
oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, current standards, the Agency will as a manufacturing process. Please note
100 mg, and 150 mg, are the subject of advise ANDA applicants to submit such that if you include your name, contact
NDA 012703, held by AstraZeneca, and labeling. information, or other information that
initially approved on April 7, 1961. Dated: October 17, 2017.
identifies you in the body of your
ELAVIL is indicated for the relief of comments, that information will be
Leslie Kux,
symptoms of depression. ELAVIL posted on https://www.regulations.gov.
Associate Commissioner for Policy.
(amitriptyline hydrochloride) oral • If you want to submit a comment
tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 [FR Doc. 2017–22892 Filed 10–20–17; 8:45 am] with confidential information that you
mg, and 150 mg, are currently listed in BILLING CODE 4164–01–P do not wish to be made available to the
the ‘‘Discontinued Drug Product List’’ public, submit the comment as a
section of the Orange Book. In the written/paper submission and in the
Federal Register of June 16, 2006 (71 FR DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
34940), FDA announced that it was HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
withdrawing approval of NDA 012703, Food and Drug Administration Written/Paper Submissions
effective June 16, 2006.
Alembic Pharmaceuticals Limited [Docket No. FDA–2007–D–0369] Submit written/paper submissions as
submitted a citizen petition dated June follows:
5, 2017 (Docket No. FDA–2017–P– Product-Specific Guidance for • Mail/Hand delivery/Courier (for
3581), under 21 CFR 10.30, requesting Methylphenidate Hydrochloride; New written/paper submissions): Dockets
that the Agency determine whether Draft Guidance for Industry; Management Staff (HFA–305), Food and
ethrower on DSK3G9T082PROD with NOTICES
ELAVIL (amitriptyline hydrochloride) Availability Drug Administration, 5630 Fishers
oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
100 mg, and 150 mg, were withdrawn HHS. • For written/paper comments
from sale for reasons of safety or ACTION: Notice of availability. submitted to the Dockets Management
effectiveness. Staff, FDA will post your comment, as
After considering the citizen petition SUMMARY: The Food and Drug well as any attachments, except for
and reviewing Agency records and Administration (FDA, the Agency, or information submitted, marked and
VerDate Sep<11>2014 20:08 Oct 20, 2017 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\23OCN1.SGM 23OCN1](https://thefederalregister.org/doc/82_FR_49235/page/2.svg)
Document Created: 2017-10-21 02:35:36
Document Modified: 2017-10-21 02:35:36
| 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. | |
| Contact | Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, [email protected] | |
| FR Citation | 82 FR 49032 |
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