[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20223-20224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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indication, be withdrawn.

DATES: Approval is withdrawn as of April 22, 2024.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, [email protected].

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