[Federal Register Volume 72, Number 150 (Monday, August 6, 2007)]
[Notices]
[Pages 43644-43645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15174]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006P-0446]


Determination That PHENERGAN (Promethazine Hydrochloride) 
Suppositories, 12.5 Milligrams and 25 Milligrams, Were Not Withdrawn 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 
PHENERGAN (promethazine hydrochloride (HCl)) suppositories, 12.5 
milligrams (mg) and 25 mg, were not withdrawn from sale for reasons of 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 promethazine HCl 
suppositories, 12.5 mg and 25 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. Sponsors of ANDAs 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 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.
    PHENERGAN (promethazine HCl) suppositories, 12.5 mg and 25 mg, are 
the subject of approved NDA 10-926 held by Wyeth Pharmaceuticals, Inc. 
(Wyeth). PHENERGAN (promethazine HCl) suppositories are indicated for, 
among other things, certain types of allergic reactions and sedation. 
Wyeth's NDA 10-926 was originally approved in 1958. In 1971, under the 
Drug Efficacy Study Implementation (DESI), FDA concluded that 
promethazine HCl rectal suppositories were effective or probably 
effective for the indications described in the Federal Register notice 
published on June 18, 1971 (DESI 6290, 36 FR 11758). In a citizen 
petition received November 1, 2006 (Docket No. 2006P-0446/CP1), 
submitted under 21 CFR 10.30, Taro Pharmaceuticals U.S.A., Inc., 
requested that the agency determine, as described in Sec.  314.161, 
whether PHENERGAN (promethazine HCl) suppositories, 12.5 mg and 25 mg, 
were withdrawn from sale for reasons of safety or effectiveness.
    The agency has determined that PHENERGAN (promethazine HCl) 
suppositories, 12.5 mg and 25 mg, were not withdrawn from sale for 
reasons of safety or effectiveness. In support of this finding, we note 
that promethazine HCl is a widely used product that has been marketed 
for many decades in many dosage forms. FDA has independently evaluated 
relevant literature and data for possible postmarketing adverse events 
and has found no information that would indicate that PHENERGAN

[[Page 43645]]

suppositories, 12.5 mg and 25 mg, were 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, PHENERGAN 
(promethazine HCl) suppositories, 12.5 mg and 25 mg, were not withdrawn 
from sale for reasons of safety or effectiveness. Accordingly, the 
agency will continue to list PHENERGAN (promethazine HCl) 
suppositories, 12.5 mg and 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 PHENERGAN (promethazine HCl) 
suppositories, 12.5 mg and 25 mg, may be approved by the agency as long 
as they meet all relevant legal and regulatory requirements for 
approval of ANDAs. If FDA determines that labeling for these drug 
products 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. E7-15174 Filed 8-3-07; 8:45 am]
BILLING CODE 4160-01-S >