[Federal Register Volume 72, Number 150 (Monday, August 6, 2007)]
[Notices]
[Page 43645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15230]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P-0160]
Determination That Daranide (Dichlorphenamide) Tablets, 50
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or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
Daranide (dichlorphenamide) Tablets, 50 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withdrawn from sale for reasons of safety or effectiveness.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 dichlorphenamide tablets, 50 mg.
FOR FURTHER INFORMATION CONTACT: Mary 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 (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 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 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listed drug was withdrawn from sale for reasons of safety or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).
Under 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.
In a citizen petition dated April 12, 2006 (Docket No. 2006P-0160/
CP1), submitted under 21 CFR 10.30, Taro Research Institute requested
that the agency determine whether Daranide Tablets, 50 mg, were
withdrawn from sale for reasons of safety or effectiveness. Daranide
(dichlorphenamide) Tablets, 50 mg, are the subject of approved NDA 11-
366 held by Merck & Co., Inc. (Merck). Daranide is indicated for
adjunctive treatment of glaucoma. Merck discontinued marketing Daranide
Tablets, 50 mg, in June 2002, and they were moved to the ``Discontinued
Drug Product List'' section of the Orange Book.
The agency has determined that Daranide Tablets, 50 mg, were not
withdrawn from sale for reasons of safety or effectiveness. The
petitioner identified no data or other information suggesting that
Daranide Tablets, 50 mg, were withdrawn from sale as a result of safety
or effectiveness concerns. 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.
After considering the citizen petition and reviewing its records,
FDA determines that, for the reasons outlined in this notice, Daranide
(dichlorphenamide) Tablets, 50 mg, were not withdrawn from sale for
reasons of safety or effectiveness. Accordingly, the agency will
continue to list Daranide (dichlorphenamide) Tablets, 50 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 Daranide
(dichlorphenamide) Tablets, 50 mg, may be approved by the agency as
long as they comply with relevant legal and regulatory requirements. 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 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15230 Filed 8-3-07; 8:45 am]
BILLING CODE 4160-01-S