[Federal Register Volume 75, Number 57 (Thursday, March 25, 2010)]
[Notices]
[Pages 14444-14445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0215] (formerly Docket No. 2008P-0006)


Determination That DIDREX (Benzphetamine Hydrochloride) Tablets, 
25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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 
DIDREX (benzphetamine hydrochloride (HCl)) Tablets, 25 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were not withdrawn from sale for reasons of safety or effectiveness.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 benzphetamine HCl 25 mg tablets, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Christine Bina, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6220, 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

[[Page 14445]]

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.
    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 Under FDA regulations, drugs are withdrawn from the list if the 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 (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.
    DIDREX (benzphetamine HCl) Tablets, 25 mg, are the subject of 
approved NDA 12-427 held by Pharmacia and Upjohn Co., a subsidiary of 
Pfizer Inc. Benzphetamine HCl 25-mg tablets are indicated in the 
management of exogenous obesity as a short-term (a few weeks) adjunct 
in a regimen of weight reduction based on caloric restriction. NDA 12-
427 was initially approved in 1960. In 1973, under the Drug Efficacy 
Study Implementation, FDA concluded that benzphetamine HCl 25-mg 
tablets are effective for the indications described in the Federal 
Register document published on February 12, 1973 (38 FR 4280). Pfizer 
Inc. ceased manufacturing DIDREX (benzphetamine HCL) Tablets, 25 mg, 
prior to September 1992. FDA received a citizen petition from Lachman 
Consultant Services, Inc., dated January 2, 2008, submitted under 21 
CFR 10.30. The petition requests that the agency determine whether 
DIDREX (benzphetamine HCL) Tablets, 25 mg, were withdrawn from sale for 
reasons of safety or effectiveness.
    FDA has reviewed its records and under Sec.  314.161, has 
determined that DIDREX (benzphetamine HCL) Tablets, 25 mg, were not 
withdrawn from sale for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
DIDREX (benzphetamine HCL) Tablets, 25 mg were withdrawn from sale as a 
result of safety or effectiveness concerns. FDA's independent 
evaluation of relevant information has uncovered no information that 
would indicate this product was withdrawn for reasons of safety or 
effectiveness. In addition, DIDREX (benzphetamine HCL) Tablets 
currently are being marketed in a 50-mg scored tablet. The lower, 25-mg 
strength of DIDREX (benzphetamine HCL) Tablets is within the effective 
dosing range (25 to 50 mg, 1 to 3 times daily) and currently can be 
obtained by breaking in half the scored 50-mg strength tablet.
    After considering the citizen petition and reviewing agency 
records, FDA determines that for the reasons outlined previously, 
DIDREX (benzphetamine HCL) Tablets, 25 mg, were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list DIDREX (benzphetamine HCl) Tablets, 25 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 DIDREX (benzphetamine 
HCl) Tablets, 25 mg, may be approved by the agency as long as they meet 
all relevant legal and regulatory requirements for the approval of 
ANDAs. If FDA determines that the labeling of this drug product should 
be revised to meet current standards, the agency will advise ANDA 
applicants to submit such labeling.

    Dated: March 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6593 Filed 3-24-10; 8:45 am]
BILLING CODE 4160-01-S