[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25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or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were not withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the list if the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