[Federal Register Volume 71, Number 135 (Friday, July 14, 2006)]
[Notices]
[Pages 40129-40130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11072]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2005P-0300 and 2005P-0319]


Determination That PHENERGAN (Promethazine Hydrochloride) 
Tablets, 12.5 Milligrams and 50 Milligrams, Were Not Withdrawn From 
Sale for Reasons of Safety or Effectiveness

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) has determined that 
PHENERGAN (promethazine hydrochloride (HCl)) tablets, 12.5 milligrams 
(mg) and 50 mg, were not withdrawn from sale for reasons of safety or 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 tablets, 12.5 mg and 
50 mg.

FOR FURTHER INFORMATION CONTACT:  Quynh Nguyen, 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 (the 1984 
amendments) (Public Law 98-417), 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 Under FDA regulations, drugs are withdrawn from the list if the 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).
    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) tablets, 12.5 mg and 50 mg, are the 
subject of approved NDA 7-935 held by Wyeth Pharmaceuticals, Inc. 
(Wyeth). PHENERGAN (promethazine HCl) tablets are indicated for, among 
other things, certain types of allergic reactions and sedation. Wyeth's 
NDA 7-935 was originally approved in 1951. In 1971, under the Drug 
Efficacy Study Implementation (DESI), FDA concluded that promethazine 
HCl tablets were effective or probably effective for the indications 
described in the Federal Register notice published on June 18, 1971 
(DESI 6290, 36 FR 11758). Wyeth discontinued sale of the 12.5 mg and 50 
mg tablets in 2004. Amide Pharmaceutical, Inc., and Peter S. Reichertz 
submitted citizen petitions dated July 28, 2005 (Docket No. 2005P-0300/
CP1), and August 10, 2005 (Docket No. 2005P-0319/CP1), respectively, 
under 21 CFR 10.30, requesting that the agency determine, as described 
in Sec.  314.161, whether PHENERGAN (promethazine HCl) tablets, 12.5 mg 
and 50 mg, were withdrawn from sale for reasons of safety or 
effectiveness.
    The agency has determined that Wyeth's PHENERGAN (promethazine HCl) 
tablets, 12.5 mg and 50 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 adverse event reports and has found no 
information that would indicate that PHENERGAN tablets, 12.5 mg and 50 
mg, were withdrawn for reasons of safety or effectiveness.
    After considering the citizen petitions (including comments 
submitted) and reviewing agency records, FDA determines that for the 
reasons outlined previously, Wyeth's PHENERGAN (promethazine HCl) 
tablets, 12.5 mg and 50 mg, were not withdrawn from sale for reasons of 
safety or effectiveness. Accordingly, the agency will continue to list 
PHENERGAN (promethazine HCl) tablets, 12.5 mg and 50 mg, in the

[[Page 40130]]

``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) tablets, 12.5 mg and 50 mg, may be approved by the 
agency as long as they meet all relevant legal and regulatory 
requirements for the approval of ANDAs.

    Dated: June 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11072 Filed 7-13-06; 8:45 am]
BILLING CODE 4160-01-S