[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Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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withdrawn from sale for reasons of safety or effectiveness.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listed drug was withdrawn from sale for reasons of safety or 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