[Federal Register Volume 65, Number 120 (Wednesday, June 21, 2000)]
[Notices]
[Pages 38561-38562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P-0585]


Determination That Fluoxetine Hydrochloride 20-Milligram Tablets 
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
determination that fluoxetine hydrochloride 20-milligram (mg) tablets 
(Prozac) were not withdrawn from sale for reasons of safety 
or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDA's) for fluoxetine hydrochloride 
20-mg tablets.

FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (the 1984 
amendments) (Public Law 98-417), which authorized the approval of 
duplicate versions of drug products approved under an ANDA procedure. 
ANDA sponsors 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 under a new drug 
application (NDA). Sponsors of ANDA's do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
NDA. The only clinical data required in an ANDA are data to show that 
the drug that is the subject of the ANDA is bioequivalent to the listed 
drug.
    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

[[Page 38562]]

Therapeutic Equivalence Evaluations,'' which is generally known as the 
``Orange Book.'' Under FDA regulations, drugs are withdrawn from the 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 (Sec. 314.162 (21 CFR 314.162)). Regulations also provide 
that the agency must make a determination as to whether a listed drug 
was withdrawn from sale for reasons of safety or effectiveness before 
an ANDA that refers to that listed drug may be approved 
(Sec. 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an 
ANDA that does not refer to a listed drug.
    On February 11, 2000, Lachman Consultant Services, Inc., submitted 
a citizen petition (Docket No. 00P-0585/CP1) under 21 CFR 10.30 to FDA. 
The petition requested that the agency determine whether fluoxetine 
hydrochloride 20-mg tablets were withdrawn from sale for reasons of 
safety or effectiveness. Fluoxetine hydrochloride 20-mg tablets are the 
subject of NDA 20-974. FDA approved NDA 20-974, held by Eli Lilly and 
Co., on March 9, 1999. On April 2, 1999, Eli Lilly and Co. informed FDA 
that it had decided not to market fluoxetine hydrochloride 20-mg 
tablets. FDA has determined that, for purposes of Secs. 314.161 and 
314.162, never marketing an approved drug product is equivalent to 
withdrawing the drug from sale.
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that Eli Lilly and Co.'s decision not to market fluoxetine 
hydrochloride 20-mg tablets was not for reasons of safety or 
effectiveness. Accordingly, the agency will continue to list fluoxetine 
hydrochloride 20-mg tablets 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. ANDA's that refer to fluoxetine hydrochloride 20-mg 
tablets may be approved by the agency.

    Dated: June 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-15556 Filed 6-20-00; 8:45 am]
BILLING CODE 4160-01-F