82 FR 41967 - Determination That ENJUVIA (Estrogens, Conjugated Synthetic B) Tablets, 0.625 Milligrams and 1.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 170 (September 5, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 170 (September 5, 2017)
| Page Range | 41967-41968 | |
| FR Document | 2017-18693 |
[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)] [Notices] [Pages 41967-41968] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18693] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-1459] Determination That ENJUVIA (Estrogens, Conjugated Synthetic B) Tablets, 0.625 Milligrams and 1.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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has determined that ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 milligrams (mg) and 1.25 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Bronwen Blass, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301- 796-5092. 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 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. ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 mg, is the subject of NDA 021443, held by Teva Branded Pharmaceutical Products R&D, Inc. (Teva), and was initially approved on May 10, 2004. ENJUVIA is indicated for treatment of moderate to severe vasomotor symptoms due to menopause and treatment of moderate to severe vaginal dryness and pain with intercourse, as well as symptoms of vulvar and vaginal atrophy due to menopause. In 2016, Teva notified FDA that ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 mg, were being discontinued, and FDA moved those drug products to the ``Discontinued Drug Product List'' section of the Orange Book. Foley & Lardner submitted a citizen petition dated March 8, 2017 (Docket No. FDA-2017-P-1459), under 21 CFR 10.30, requesting that the Agency determine whether ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 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 ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 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 ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 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 these drug products were withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 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 ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 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. [[Page 41968]] Dated: August 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-18693 Filed 9-1-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 41967
applications are often hundreds of pages safety or effectiveness. This initially approved on May 10, 2004.
long, expensive to reproduce and determination will allow FDA to ENJUVIA is indicated for treatment of
transmit, and administratively approve abbreviated new drug moderate to severe vasomotor symptoms
inefficient, as staff reviewing different applications (ANDAs) for ENJUVIA due to menopause and treatment of
parts of the application are located in (estrogens, conjugated synthetic B) moderate to severe vaginal dryness and
different physical locations and must tablets, 0.625 mg and 1.25 mg, if all pain with intercourse, as well as
receive hard copies of the material. other legal and regulatory requirements symptoms of vulvar and vaginal atrophy
However, beginning in 2016 and 2017, are met. due to menopause.
initial and SAE PACE applications, FOR FURTHER INFORMATION CONTACT: In 2016, Teva notified FDA that
respectively, are being submitted via a Bronwen Blass, Center for Drug ENJUVIA (estrogens, conjugated
new automated, electronic submission Evaluation and Research, Food and synthetic B) tablets, 0.625 mg and 1.25
process. As with initial applications, an Drug Administration, 10903 New mg, were being discontinued, and FDA
application also must be submitted for Hampshire Ave., Bldg. 51, Rm. 6228, moved those drug products to the
a PO that seeks to expand its service Silver Spring, MD 20993–0002, 301– ‘‘Discontinued Drug Product List’’
area and/or add a new service site, and 796–5092. section of the Orange Book.
with OMB approval, an automated Foley & Lardner submitted a citizen
SUPPLEMENTARY INFORMATION: In 1984,
application process will now also be petition dated March 8, 2017 (Docket
Congress enacted the Drug Price
required of PACE organizations No. FDA–2017–P–1459), under 21 CFR
Competition and Patent Term
submitting service area expansion 10.30, requesting that the Agency
Restoration Act of 1984 (Pub. L. 98–417)
applications. The collection specific to determine whether ENJUVIA (estrogens,
(the 1984 amendments), which
the application was approved by OMB conjugated synthetic B) tablets, 0.625
authorized the approval of duplicate
for a 3-year period, which expires mg and 1.25 mg, were withdrawn from
versions of drug products under an
March 31, 2020. Approval is now sale for reasons of safety or
ANDA procedure. ANDA applicants
requested for revisions to this currently- effectiveness.
approved collection, which includes must, with certain exceptions, show that
the drug for which they are seeking After considering the citizen petition
modifications to the PACE application. and reviewing Agency records and
Form Number: CMS–10631 (OMB approval contains the same active
ingredient in the same strength and based on the information we have at this
control number: 0938–1326); Frequency: time, FDA has determined under
Once and occasionally; Affected Public: dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was § 314.161 that ENJUVIA (estrogens,
Private sector (Business or other for- conjugated synthetic B) tablets, 0.625
profits and Not-for-profit institutions) previously approved. ANDA applicants
do not have to repeat the extensive mg and 1.25 mg, were not withdrawn
and State, Local, or Tribal Governments; for reasons of safety or effectiveness.
Number of Respondents: 730; Total clinical testing otherwise necessary to
gain approval of a new drug application The petitioner has identified no data or
Annual Responses: 84; Total Annual other information suggesting that these
Hours: 4,626. (For policy questions (NDA).
The 1984 amendments include what products were withdrawn for reasons of
regarding this collection contact Stacy safety or effectiveness. We have
Davis at 410–786–7813.) is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. carefully reviewed our files for records
Dated: August 30, 2017. 355(j)(7)), which requires FDA to concerning the withdrawal of ENJUVIA
William N. Parham, III, publish a list of all approved drugs. (estrogens, conjugated synthetic B)
Director, Paperwork Reduction Staff, Office FDA publishes this list as part of the tablets, 0.625 mg and 1.25 mg, from sale.
of Strategic Operations and Regulatory ‘‘Approved Drug Products With We have also independently evaluated
Affairs. Therapeutic Equivalence Evaluations,’’ relevant literature and data for possible
[FR Doc. 2017–18738 Filed 9–1–17; 8:45 am] which is known generally as the postmarketing adverse events. We have
BILLING CODE 4120–01–P ‘‘Orange Book.’’ Under FDA regulations, found no information that would
drugs are removed from the list if the indicate that these drug products were
Agency withdraws or suspends withdrawn from sale for reasons of
DEPARTMENT OF HEALTH AND approval of the drug’s NDA or ANDA safety or effectiveness.
HUMAN SERVICES for reasons of safety or effectiveness or Accordingly, the Agency will
if FDA determines that the listed drug continue to list ENJUVIA (estrogens,
Food and Drug Administration
was withdrawn from sale for reasons of conjugated synthetic B) tablets, 0.625
[Docket No. FDA–2017–P–1459] safety or effectiveness (21 CFR 314.162). mg and 1.25 mg, in the ‘‘Discontinued
A person may petition the Agency to Drug Product List’’ section of the Orange
Determination That ENJUVIA determine, or the Agency may Book. The ‘‘Discontinued Drug Product
(Estrogens, Conjugated Synthetic B) determine on its own initiative, whether List’’ delineates, among other items,
Tablets, 0.625 Milligrams and 1.25 a listed drug was withdrawn from sale drug products that have been
Milligrams, Were Not Withdrawn From for reasons of safety or effectiveness. discontinued from marketing for reasons
Sale for Reasons of Safety or This determination may be made at any other than safety or effectiveness.
Effectiveness time after the drug has been withdrawn ANDAs that refer to ENJUVIA
AGENCY: Food and Drug Administration, from sale, but must be made prior to (estrogens, conjugated synthetic B)
HHS. approving an ANDA that refers to the tablets, 0.625 mg and 1.25 mg, may be
listed drug (§ 314.161 (21 CFR 314.161)). approved by the Agency as long as they
mstockstill on DSK30JT082PROD with NOTICES
ACTION: Notice.
FDA may not approve an ANDA that meet all other legal and regulatory
SUMMARY: The Food and Drug does not refer to a listed drug. requirements for the approval of
Administration (FDA or Agency) has ENJUVIA (estrogens, conjugated ANDAs. If FDA determines that labeling
determined that ENJUVIA (estrogens, synthetic B) tablets, 0.625 mg and 1.25 for this drug product should be revised
conjugated synthetic B) tablets, 0.625 mg, is the subject of NDA 021443, held to meet current standards, the Agency
milligrams (mg) and 1.25 mg, were not by Teva Branded Pharmaceutical will advise ANDA applicants to submit
withdrawn from sale for reasons of Products R&D, Inc. (Teva), and was such labeling.
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![41968 Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
Dated: August 28, 2017. • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
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mstockstill on DSK30JT082PROD with NOTICES
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Electronic Submissions copies total. One copy will include the 796–3842; or Aaron Sherman, Center for
Submit electronic comments in the information you claim to be confidential Drug Evaluation and Research, Food
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Document Created: 2017-09-02 03:24:57
Document Modified: 2017-09-02 03:24:57
| 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. | |
| Contact | Bronwen Blass, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301- 796-5092. | |
| FR Citation | 82 FR 41967 |
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