[Federal Register: May 20, 2005 (Volume 70, Number 97)]
[Notices]
[Page 29329-29330]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my05-108]
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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Capsules Were Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the list if the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drug was withdrawn from sale for reasons of safety or effectiveness (21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