[Federal Register Volume 73, Number 136 (Tuesday, July 15, 2008)]
[Notices]
[Pages 40582-40583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-P-0326]


Determination That SANOREX (Mazindol) Tablets 1 and 2 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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) is announcing its 
determination that SANOREX (mazindol) Tablets, 1 and 2 milligrams (mg), 
were not withdrawn from sale for reasons of safety or effectiveness. 
This determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for mazindol tablets if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Carol E. Drew, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6306 Silver Spring, MD 20993-0002, 301-
796-3601.

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 
applicants 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. ANDA applicants do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (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.

[[Page 40583]]

    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 known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed 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 (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 August 20, 2007, AAIPharma submitted a citizen petition (Docket 
No. 2007P-0326/CP1) to FDA under 21 CFR 10.30. The petition requests 
that the agency determine whether SANOREX (mazindol) Tablets, 1 and 2 
mg (NDA 17-247), manufactured by Novartis Pharmaceuticals Corp. 
(Novartis), were withdrawn from sale for reasons of safety or 
effectiveness. SANOREX is approved for the management of exogenous 
obesity as a short term adjunct in a regimen of weight reduction based 
on caloric restriction in certain patients. SANOREX Tablets were 
approved on June 14, 1973. SANOREX Tablets were discontinued in 1999, 
and the drug product was moved from the prescription drug product list 
to the ``Discontinued Drug Product List'' section of the Orange Book.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that SANOREX Tablets, 1 and 2 mg, were not withdrawn from 
sale for reasons of safety or effectiveness. The petitioner identified 
no data or other information suggesting that SANOREX Tablets, 1 and 2 
mg, were withdrawn for reasons of safety or effectiveness. FDA has 
independently evaluated relevant literature and data for possible 
postmarketing adverse events and has found no information that would 
indicate that this product was withdrawn from sale for reasons of 
safety or effectiveness. Accordingly, the agency will continue to list 
SANOREX Tablets 1 and 2 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 SANOREX (mazindol) Tablets, 1 and 2 
mg, may be approved by the agency if all other legal and regulatory 
requirements for the approval of ANDAs are met. If FDA determines that 
labeling for this drug product should be revised to meet current 
standards, the agency will advise ANDA applicants to submit such 
labeling.

    Dated: July 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15998 Filed 7-14-08; 8:45 am]
BILLING CODE 4160-01-S