[Federal Register: July 14, 2006 (Volume 71, Number 135)]
[Notices]
[Page 40129-40130]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy06-95]
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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Tablets, 12.5 Milligrams and 50 Milligrams, Were Not Withdrawn From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.
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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(mg) and 50 mg, were not withdrawn from sale for reasons of safety or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 Under FDA regulations, drugs are withdrawn from the list if the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