[Federal Register Volume 69, Number 180 (Friday, September 17, 2004)]
[Notices]
[Pages 56069-56070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004P-0162]


Determination That ZOLOFT (Sertraline Hydrochloride) Tablets, 150 
Milligrams and 200 Milligrams, Were Not Withdrawn From Sale for Reasons 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) has determined that 
ZOLOFT (sertraline hydrochloride (HCl)) Tablets, 150 milligrams (mg) 
and 200 mg (new drug application (NDA) 19-839), were not withdrawn from 
sale for reasons of safety or effectiveness. This determination will 
allow FDA to approve abbreviated new drug applications (ANDAs) for 
sertraline HCl tablets, 150 mg and 200 mg.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, 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 (Public Law 98-417) 
(the 1984 amendments), 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 
typically a version of the drug that was previously approved. Sponsors 
of ANDAs 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 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 Under FDA regulations, drugs are withdrawn from the list if the 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)).
    Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must 
determine 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. FDA may not approve an ANDA that does not refer to a 
listed drug.
    ZOLOFT Tablets, 150 mg and 200 mg, are the subject of approved NDA 
19-839 held by Pfizer, Inc. (Pfizer). ZOLOFT (sertraline HCl) is 
indicated for the treatment of major depressive disorder, obsessive-
compulsive disorder, panic disorder, posttraumatic stress disorder, 
premenstrual dysphoric disorder, and social anxiety disorder. Lachman 
Consultant Services, Inc., submitted a citizen petition dated April 5, 
2004 (Docket No. 2004P-0162/CP1), under 21 CFR 10.30, requesting that 
the agency determine whether ZOLOFT (sertraline HCl) Tablets, 150 mg 
and 200 mg, were withdrawn from sale for reasons of safety or 
effectiveness.
    The agency has determined that Pfizer's ZOLOFT Tablets, 150 mg and 
200 mg, were not withdrawn from sale for reasons of safety or 
effectiveness. Pfizer has never commercially marketed ZOLOFT Tablets, 
150 mg and 200 mg. In previous instances (see, e.g., 67 FR 79640 at 
79641, December 30, 2002 (addressing a relisting request for Diazepam 
Autoinjector)), FDA has concluded that, for purposes of Sec. Sec.  
314.161 and 314.162, never marketing an approved drug product is 
equivalent to withdrawing the drug from sale. There is no indication 
that Pfizer's decision not to market ZOLOFT Tablets, 150 mg and 200 mg, 
commercially is a function of safety or effectiveness concerns, and the 
petitioner has identified no data or other information suggesting that 
ZOLOFT Tablets, 150 mg and 200 mg, pose a safety risk. FDA's 
independent evaluation of relevant information has uncovered nothing 
that would indicate this product was withdrawn for reasons of safety or 
effectiveness.
    After considering the citizen petition and reviewing agency 
records, FDA determines that for the reasons outlined

[[Page 56070]]

above, ZOLOFT Tablets, 150 mg and 200 mg, were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list ZOLOFT Tablets, 150 mg and 200 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 ZOLOFT Tablets, 150 
mg and/or 200 mg, may be approved by the agency.

    Dated: September 10, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-21022 Filed 9-16-04; 8:45 am]
BILLING CODE 4160-01-S