Notice2024-05982
Eli Lilly and Company; Withdrawal of Approval of SARAFEM (Fluoxetine Hydrochloride) Capsules, Equivalent to 10 Milligrams Base and Equivalent to 20 Milligrams Base, Including the Premenstrual Dysphoric Disorder Indication Approved Under New Drug Application 018936
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 21, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of SARAFEM (fluoxetine hydrochloride (HCl)) capsules, equivalent to (EQ) 10 milligrams (mg) base and EQ 20 mg base, including the premenstrual dysphoric disorder (PMDD) indication, approved under new drug application (NDA) 018936. This NDA is held by Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 (Lilly). Lilly notified the Agency in writing that SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20 mg base, indicated for the treatment of PMDD, was no longer marketed and requested that the approval of SARAFEM (fluoxetine HCl) capsules, including the PMDD indication, be withdrawn.
Full Text
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<title>Federal Register, Volume 89 Issue 56 (Thursday, March 21, 2024)</title>
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[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20223-20224]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05982]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0644]
Eli Lilly and Company; Withdrawal of Approval of SARAFEM
(Fluoxetine Hydrochloride) Capsules, Equivalent to 10 Milligrams Base
and Equivalent to 20 Milligrams Base, Including the Premenstrual
Dysphoric Disorder Indication Approved Under New Drug Application
018936
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of SARAFEM (fluoxetine hydrochloride (HCl))
capsules, equivalent to (EQ) 10 milligrams (mg) base and EQ 20 mg base,
including the premenstrual dysphoric disorder (PMDD) indication,
approved under new drug application (NDA) 018936. This NDA is held by
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285
(Lilly). Lilly notified the Agency in writing that SARAFEM (fluoxetine
HCl) capsules, EQ 10 mg base and EQ 20 mg base, indicated for the
treatment of PMDD, was no longer marketed and requested that the
approval of SARAFEM (fluoxetine HCl) capsules, including the PMDD
indication, be withdrawn.
DATES: Approval is withdrawn as of April 22, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#a7eccecac5c2d5cbde89ebc2cfd5c1c2cbc3e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="23684a4e4146514f5a0d6f464b5145464f47634547420d4b4b500d444c55">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On December 29, 1987, FDA approved NDA
018936 for PROZAC (fluoxetine HCl) capsules, EQ 20 mg base, for major
depressive disorder. On July 6, 2000, FDA approved a supplement to NDA
018936 for SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20
mg base, indicated for the treatment of PMDD. SARAFEM (fluoxetine HCl)
capsules are only approved for the PMDD indication. SARAFEM (fluoxetine
HCl) capsules and PROZAC (fluoxetine HCl) capsules, EQ 10 mg base and
EQ 20 mg base, were marketed by Lilly under the same NDA with distinct
labeling, including distinct Prescribing Information, carton and
container labels, and labeling for patients and caregivers.
On June 10, 2010, Lilly informed FDA that it had discontinued
marketing of SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20
mg base. On August 4, 2023, Lilly requested, in writing, that FDA
withdraw approval of SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base
and EQ 20 mg base, including the PMDD indication, under Sec.
314.150(c) (21 CFR 314.150(c)). Lilly also waived its opportunity for a
[[Page 20224]]
hearing. Withdrawal of approval of an application under Sec.
314.150(c) is without prejudice to refiling.
Therefore, approval of SARAFEM (fluoxetine HCl) capsules, EQ 10 mg
base and EQ 20 mg base, including the PMDD indication approved under
NDA 018936, is hereby withdrawn as of April 22, 2024. Withdrawal of
approval of SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20
mg base, including the PMDD indication approved under NDA 018936, does
not affect approval of PROZAC (fluoxetine HCl) capsules, EQ 10 mg base,
EQ 20 mg base, EQ 40 mg base, and EQ 60 mg base, or any other
indication approved under NDA 018936. Introduction or delivery for
introduction into interstate commerce of SARAFEM (fluoxetine HCl)
capsules, EQ 10 mg base and EQ 20 mg base, without an approved NDA
violates sections 505(a) and 301(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05982 Filed 3-20-24; 8:45 am]
BILLING CODE 4164-01-P
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