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Federal Register / Vol. 72, No.

150 / Monday, August 6, 2007 / Notices 43645

suppositories, 12.5 mg and 25 mg, were Lane, Rockville, MD 20857, 301–594– The agency has determined that
withdrawn from sale for reasons of 2041. Daranide Tablets, 50 mg, were not
safety or effectiveness. withdrawn from sale for reasons of
SUPPLEMENTARY INFORMATION: In 1984, safety or effectiveness. The petitioner
After considering the citizen petition
Congress enacted the Drug Price identified no data or other information
and reviewing its records, FDA
Competition and Patent Term suggesting that Daranide Tablets, 50 mg,
determines that, for the reasons outlined
Restoration Act of 1984 (Public Law 98– were withdrawn from sale as a result of
in this notice, PHENERGAN
417) (the 1984 amendments), which safety or effectiveness concerns. FDA
(promethazine HCl) suppositories, 12.5
authorized the approval of duplicate has independently evaluated relevant
mg and 25 mg, were not withdrawn
versions of drug products approved literature and data for possible
from sale for reasons of safety or
under an ANDA procedure. ANDA postmarketing adverse events and has
effectiveness. Accordingly, the agency
sponsors must, with certain exceptions, found no information that would
will continue to list PHENERGAN
show that the drug for which they are indicate that this product was
(promethazine HCl) suppositories, 12.5
seeking approval contains the same withdrawn from sale for reasons of
mg and 25 mg, in the ‘‘Discontinued
active ingredient in the same strength safety or effectiveness.
Drug Product List’’ section of the Orange
and dosage form as the ‘‘listed drug,’’ After considering the citizen petition
Book. The ‘‘Discontinued Drug Product
which is a version of the drug that was and reviewing its records, FDA
List’’ delineates, among other items,
previously approved. ANDA applicants determines that, for the reasons outlined
drug products that have been
do not have to repeat the extensive in this notice, Daranide
discontinued from marketing for reasons
clinical testing otherwise necessary to (dichlorphenamide) Tablets, 50 mg,
other than safety or effectiveness.
gain approval of a new drug application were not withdrawn from sale for
ANDAs that refer to PHENERGAN
(NDA). The only clinical data required reasons of safety or effectiveness.
(promethazine HCl) suppositories, 12.5
in an ANDA are data to show that the Accordingly, the agency will continue
mg and 25 mg, may be approved by the
drug that is the subject of the ANDA is to list Daranide (dichlorphenamide)
agency as long as they meet all relevant
bioequivalent to the listed drug. Tablets, 50 mg, in the ‘‘Discontinued
legal and regulatory requirements for
approval of ANDAs. If FDA determines The 1984 amendments include what Drug Product List’’ section of the Orange
that labeling for these drug products is now section 505(j)(7) of the Federal Book. The ‘‘Discontinued Drug Product
should be revised to meet current Food, Drug, and Cosmetic Act (21 U.S.C. List’’ delineates, among other items,
standards, the agency will advise ANDA 355(j)(7)), which requires FDA to drug products that have been
applicants to submit such labeling. publish a list of all approved drugs. discontinued from marketing for reasons
Dated: July 30, 2007.
FDA publishes this list as part of the other than safety or effectiveness.
‘‘Approved Drug Products With ANDAs that refer to Daranide
Randall W. Lutter,
Therapeutic Equivalence Evaluations,’’ (dichlorphenamide) Tablets, 50 mg, may
Deputy Commissioner for Policy. which is generally known as the be approved by the agency as long as
[FR Doc. E7–15174 Filed 8–3–07; 8:45 am] ‘‘Orange Book.’’ Under FDA regulations, they comply with relevant legal and
BILLING CODE 4160–01–S drugs are removed from the list if the regulatory requirements. If FDA
agency withdraws or suspends approval determines that labeling for this drug
of the drug’s NDA or ANDA for reasons product should be revised to meet
DEPARTMENT OF HEALTH AND of safety or effectiveness, or if FDA current standards, the agency will
HUMAN SERVICES determines that the listed drug was advise ANDA applicants to submit such
withdrawn from sale for reasons of labeling.
Food and Drug Administration
safety or effectiveness (21 CFR 314.162). Dated: July 30, 2007.
Under 21 CFR 314.161(a)(1), the Randall W. Lutter,
[Docket No. 2006P–0160]
agency must determine whether a listed Deputy Commissioner for Policy.
Determination That Daranide drug was withdrawn from sale for [FR Doc. E7–15230 Filed 8–3–07; 8:45 am]
(Dichlorphenamide) Tablets, 50 reasons of safety or effectiveness before
BILLING CODE 4160–01–S
Milligrams, Were Not Withdrawn From an ANDA that refers to that listed drug
Sale for Reasons of Safety or may be approved. FDA may not approve
Effectiveness an ANDA that does not refer to a listed DEPARTMENT OF HEALTH AND
drug. HUMAN SERVICES
AGENCY: Food and Drug Administration, In a citizen petition dated April 12,
HHS. 2006 (Docket No. 2006P–0160/CP1), National Institutes of Health
ACTION: Notice. submitted under 21 CFR 10.30, Taro
Research Institute requested that the Government-Owned Inventions;
SUMMARY: The Food and Drug agency determine whether Daranide Availability for Licensing
Administration (FDA) has determined Tablets, 50 mg, were withdrawn from AGENCY: National Institutes of Health,
that Daranide (dichlorphenamide) sale for reasons of safety or Public Health Service, HHS.
Tablets, 50 milligrams (mg), were not effectiveness. Daranide ACTION: Notice.
withdrawn from sale for reasons of (dichlorphenamide) Tablets, 50 mg, are
safety or effectiveness. This the subject of approved NDA 11–366 SUMMARY: The inventions listed below
determination will allow FDA to held by Merck & Co., Inc. (Merck). are owned by an agency of the U.S.
approve abbreviated new drug Daranide is indicated for adjunctive Government and are available for
applications (ANDAs) for treatment of glaucoma. Merck licensing in the U.S. in accordance with
sroberts on PROD1PC70 with NOTICES

dichlorphenamide tablets, 50 mg. discontinued marketing Daranide 35 U.S.C. 207 to achieve expeditious
FOR FURTHER INFORMATION CONTACT: Tablets, 50 mg, in June 2002, and they commercialization of results of
Mary Catchings, Center for Drug were moved to the ‘‘Discontinued Drug federally-funded research and
Evaluation and Research (HFD–7), Food Product List’’ section of the Orange development. Foreign patent
and Drug Administration, 5600 Fishers Book. applications are filed on selected

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