[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)]
[Notices]
[Pages 3903-3904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1849]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96P-0316]
Determination That Minocycline Hydrochloride Tablets 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Withdrawn From Sale for Reasons of Safety or Effectiveness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
minocycline hydrochloride tablets were not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDA's) for minocycline
hydrochloride tablets.
FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, 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 (Pub. L. 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 a
version of the drug that was previously approved under a new drug
application (NDA). Sponsors of ANDA's 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 included what is now section 505(j)(6) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(6)), 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 Under FDA regulations, drugs are withdrawn from the list if the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listed drug was withdrawn from sale for reasons of safety or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). Regulations also provide that the
agency must make a determination as to
[[Page 3904]]
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.
In a citizen petition dated August 26, 1996 (Docket No. 96P-0316/
CP), submitted in accordance with 21 CFR 314.122, Clausen & Associates,
Inc., requested that the agency determine whether minocycline
hydrochloride tablets were withdrawn from sale for reasons of safety or
effectiveness. Minocycline hydrochloride (Minocin) tablets are the
subject of approved NDA 50-451 held by Lederle Laboratories. In 1996,
Lederle withdrew minocycline hydrochloride tablets from sale.
FDA has reviewed its records and, under Sec. 314.161, has
determined that minocycline hydrochloride tablets were not withdrawn
from sale for reasons of safety or effectiveness. Accordingly, the
agency will maintain minocycline hydrochloride tablets 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. ANDA's that refer to minocycline
hydrochloride tablets may be approved by the agency.
Dated: January 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-1849 Filed 1-26-98; 8:45 am]
BILLING CODE 4160-01-F