[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Notices]
[Pages 10805-10806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4925]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-P-0435 and FDA-2008-P-0554]
Determination That DOVONEX (Calcipotriene) Ointment, 0.005%, 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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) is announcing its
determination that DOVONEX (calcipotriene) Ointment, 0.005%, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for calcipotriene Ointment, 0.005%, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire
[[Page 10806]]
Ave., Bldg. 51, rm. 6358, Silver Spring, MD 20993-0002, 301-796-3601.
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
applicants 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. ANDA applicants 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 known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed 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.
DOVONEX (calcipotriene) Ointment, 0.005%, is the subject of NDA 20-
273, held by LEO Pharmaceutical Products Ltd. (LEO) and initially
approved on December 29, 1993. DOVONEX is indicated for the treatment
of plaque psoriasis in adults. In its annual report dated February 28,
2008, LEO notified FDA that DOVONEX (calcipotriene) Ointment, 0.005%,
had been discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated July 25, 2008 (Docket No. FDA-2008-P-0435), under 21 CFR 10.30,
requesting that the agency determine whether DOVONEX (calcipotriene)
Ointment, 0.005%, was withdrawn from sale for reasons of safety or
effectiveness. A second citizen petition was submitted by Mya Thomae
Consulting, Inc., dated October 13, 2008 (Docket No. FDA-2008-P-0554),
requesting that the agency determine whether DOVONEX (calcipotriene)
Ointment, 0.005%, was withdrawn from sale for reasons of safety or
effectiveness.
FDA has reviewed its records and, under Sec. 314.161, has
determined that DOVONEX (calcipotriene) Ointment, 0.005%, was not
withdrawn from sale for reasons of safety or effectiveness. The
petitioners identified no data or other information suggesting that
DOVONEX (calcipotriene) Ointment, 0.005%, was withdrawn for reasons of
safety or effectiveness. FDA has independently evaluated relevant
literature and data for possible postmarketing adverse events and has
found no information that would indicate that this product was
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list DOVONEX (calcipotriene)
Ointment, 0.005%, 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 DOVONEX (calcipotriene) Ointment, 0.005%, may be approved by
the agency if all other legal and regulatory requirements for the
approval of ANDAs are met. If FDA determines that labeling for this
drug product should be revised to meet current standards, the agency
will advise ANDA applicants to submit such labeling.
Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4925 Filed 3-8-10; 8:45 am]
BILLING CODE 4160-01-S