[Federal Register Volume 67, Number 244 (Thursday, December 19, 2002)]
[Notices]
[Pages 77796-77797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31910]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02P-0127]


Determination That PHENERGAN (Promethazine Hydrochloride 
Injection USP) 25 Milligrams/Milliliter, 10 Milliliters, Was 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Withdrawn From Sale for Reasons of Safety or Effectiveness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) injection USP) 25 
milligrams (mg)/milliliter (mL), 10 mL, was not withdrawn from sale for 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 injection USP 25 mg/mL, 10 mL.

[[Page 77797]]


FOR FURTHER INFORMATION CONTACT: Nicole Mueller, 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 under a new drug 
application (NDA). Sponsors of ANDAs do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
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 Under FDA regulations, drugs are withdrawn from the list if the 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 injection USP) 25 mg/mL, 10 mL, is the 
subject of approved NDA 08-857 held by Wyeth Pharmaceuticals, a 
division of Wyeth. PHENERGAN (promethazine HCl injection USP) 25 mg/mL, 
10 mL, is indicated for certain types of allergic reactions and 
sedation. In a citizen petition dated March 25, 2002 (Docket No. 02P-
0127), submitted under Sec.  314.161 and 21 CFR 10.30, PharmaForce, 
Inc., requested that the agency determine whether PHENERGAN 
(promethazine HCl injection USP) 25 mg/mL, 10 mL, was withdrawn from 
sale for reasons of safety or effectiveness. The petitioner seeks this 
determination in preparation for filing an ANDA for promethazine HCl 
injection USP 25 mg/mL, 10 mL.
    The agency has determined that Wyeth's PHENERGAN (promethazine HCl 
injection USP) 25 mg/mL, 10 mL, was not withdrawn from sale for reasons 
of safety or effectiveness. In support of this finding, we note that 
Wyeth continues to market PHENERGAN for injection in 25 mg/mL and 50 
mg/mL, 1-mL vials. The 25 mg/mL, 10 mL product is a multidose vial 
consisting of the same drug as the 25 mg/mL and 50 mg/mL, 1-mL vials. 
Also, promethazine HCl is a widely used product that has been marketed 
for many decades in many dosage forms. Although one potential concern 
with any multidose injectable product is the possibility of accidental 
overdose, there is no evidence that the withdrawal from the market of 
PHENERGAN (promethazine HCl injection) 25 mg/mL, 10 mL, was in any way 
connected to accidental overdose. FDA has independently evaluated 
relevant literature and data for adverse event reports and has found no 
information that would indicate this product was withdrawn for reasons 
of safety or effectiveness.
    After considering the citizen petition and reviewing its records, 
FDA determines that, for the reasons outlined previously, Wyeth's 
PHENERGAN (promethazine HCl injection USP) 25 mg/mL, 10 mL, was not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will continue to list PHENERGAN (promethazine 
HCl injection USP) 25 mg/mL, 10 mL, 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 
injection USP) 25 mg/mL, 10 mL, may be approved by the agency.

    Dated: December 8, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-31910 Filed 12-18-02; 8:45 am]
BILLING CODE 4160-01-S