[Federal Register: May 16, 2005 (Volume 70, Number 93)]
[Notices]
[Page 25832-25833]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my05-54]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2002P-0312 and 2002P-0367 (formerly Docket Nos. 02P-0312
and 02P-0367)]
CollaGenex Pharmaceuticals, Inc.; Withdrawal of Approval of a New
Drug Application; Determination That Doxycycline Hyclate 20-Milligram
Capsules Were Not Withdrawn From Sale for Reasons of Safety or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) is withdrawing approval
of one new drug application (NDA). CollaGenex Pharmaceuticals, Inc.,
notified the agency in writing that PERIOSTAT (doxycycline hyclate) 20-
milligram (mg) capsules were no longer marketed and requested that
approval of NDA 50-774 be withdrawn. FDA has determined that PERIOSTAT
(doxycycline hyclate) 20-mg capsules were not withdrawn from sale for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 doxycycline
hyclate 20-mg capsules.
DATES: The withdrawal of approval of NDA 50-744 is effective June 15,
2005.
FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
[[Page 25833]]
I. Withdrawal of Approval of NDA 50-744
CollaGenex Pharmaceutical, Inc. (CollaGenex), is the holder of NDA
50-744 for PERIOSTAT (doxycycline hyclate) 20-mg capsules. In a letter
dated September 24, 2001, CollaGenex informed FDA that this drug
product is no longer marketed and said it ``is hereby withdrawing NDA
50-744.'' In a citizen petition dated July 10, 2002 (Docket No. 2002P-
0312/CP1), CollaGenex requested that FDA withdraw approval of the
application. The applicant has, by its request, waived its opportunity
for a hearing. Therefore, under section 505(e) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research,
approval of NDA 50-744 and all amendments and supplements thereto, is
hereby withdrawn.
II. Determination That Doxycycline Hyclate 20-Mg Capsules Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
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. 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
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) (21
CFR 314.161(a)), the agency may make a determination as to whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness at any time if the drug has been voluntarily withdrawn
from sale.
In its July 10, 2002, citizen petition, CollaGenex requested that
FDA refuse to approve any ANDA for a generic version of doxycycline
hyclate 20-mg capsules until FDA determines that PERIOSTAT (doxycycline
hyclate) 20-mg capsules were not withdrawn for reasons of safety or
effectiveness. CollaGenex also requested that PERIOSTAT (doxycycline
hyclate) 20-mg capsules be moved to the ``Discontinued Drug Product
List'' of the Orange Book and that FDA publish a notice in the Federal
Register withdrawing approval of PERIOSTAT (doxycycline hyclate) 20-mg
capsules. CollaGenex noted in its petition that it now has an approved
NDA for a tablet version of PERIOSTAT. On July 10, 2002, CollaGenex
also filed a petition for stay of action (Docket No. 2002P-0312/PSA1)
requesting that FDA stay approval or receipt of any ANDA for a generic
version of PERIOSTAT capsules pending final resolution of the issues in
CollaGenex's citizen petition. In a citizen petition dated August 13,
2002 (Docket No. 2002P-0367/CP1), submitted under 21 CFR 10.25(a),
10.30, 314.122, and 314.161, West-ward Pharmaceutical Corp., requested
that FDA determine whether PERIOSTAT (doxycycline hyclate) 20-mg
capsules were withdrawn from sale for reasons of safety or
effectiveness. This Federal Register notice resolves all such issues in
the citizen petitions referenced in this document.
FDA has reviewed its records and, under Sec. 314.161, has
determined that PERIOSTAT (doxycycline hyclate) 20-mg capsules were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will list doxycycline hyclate 20-mg capsules in
the ``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' identifies, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs for doxycycline hyclate 20-mg
capsules may be approved by the agency.
Dated: May 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9624 Filed 5-13-05; 8:45 am]
BILLING CODE 4160-01-S