[Federal Register Volume 70, Number 97 (Friday, May 20, 2005)]
[Notices]
[Pages 29329-29330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10032]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket 2004P-0220]


Determination That ZITHROMAX (Azithromycin) 250-Milligram Oral 
Capsules Were Not Withdrawn From Sale for Reasons of Safety or 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 
ZITHROMAX (azithromycin) 250-milligram (mg) oral capsules were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for azithromycin 250-mg oral capsules.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, 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 
typically 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 Under FDA regulations, drugs are withdrawn from the list if the 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 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.
    ZITHROMAX (azithromycin) 250-mg oral capsules are the subject of 
NDA 50-670 held by Pfizer, Inc. (Pfizer). FDA approved NDA 50-670 on 
November 1, 1991. In February 1994, Pfizer submitted NDA 50-711 for 
ZITHROMAX (azithromycin) 250-mg tablets. Pfizer explained that the new 
dosage form was intended to replace the capsule formulation. Pfizer 
decided to change the dosage form from capsules to tablets because 
tablets do not have a

[[Page 29330]]

food effect. In its February 15, 1994, letter accompanying NDA 50-711, 
Pfizer explained that the tablets are bioequivalent to the capsule 
formulation and ``* * * unlike the capsule, can be taken without regard 
to meals.'' After NDA 50-711 was approved, Pfizer decided not to market 
the capsule formulation and ZITHROMAX (azithromycin) 250-mg oral 
capsules were moved from the prescription drug product list to 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.
    In a citizen petition submitted under 21 CFR 10.30 dated May 4, 
2004 (Docket No. 2004P-0220), as amended by a letter dated May 17, 
2004, Wapner, Newman, Wigrizer & Brecher requested that FDA determine 
whether ZITHROMAX (azithromycin) 250-mg oral capsules were withdrawn 
from sale for reasons of safety or effectiveness. The agency has 
determined that ZITHROMAX (azithromycin) 250-mg oral capsules were not 
withdrawn from sale for reasons of safety or effectiveness. The 
petitioners identified no data or other information suggesting that 
ZITHROMAX (azithromycin) 250-mg oral capsules were withdrawn from sale 
as a result of safety or effectiveness concerns. FDA has independently 
evaluated relevant literature and data 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 agency 
records, FDA determines that, for the reasons outlined in this 
document, ZITHROMAX (azithromycin) 250-mg oral capsules, approved under 
NDA 50-670, were not withdrawn from sale for reasons of safety or 
effectiveness. Accordingly, the agency will continue to list ZITHROMAX 
(azithromycin) 250-mg oral capsules in the ``Discontinued Drug Product 
List'' section of the Orange Book. As a result, ANDAs that refer to 
ZITHROMAX (azithromycin) 250-mg oral capsules may be approved by the 
agency.

    Dated: May 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10032 Filed 5-19-05; 8:45 am]
BILLING CODE 4160-01-S