[Federal Register: September 17, 2004 (Volume 69, Number 180)]
[Notices]
[Page 56069-56070]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se04-71]
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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Milligrams and 200 Milligrams, Were Not Withdrawn From Sale for Reasons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and 200 mg (new drug application (NDA) 19-839), were not withdrawn from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 Under FDA regulations, drugs are withdrawn from the list if the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