Notice: Determination That DOVONEX (Calcipotriene) Ointment, 0.005%, Was 
Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Federal Register: March 9, 2010 (Volume 75, Number 45)             
                  Page 10805-10806

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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withdrawn from sale for reasons of safety or effectiveness.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listed drug was withdrawn from sale for reasons of safety or 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withdrawn from sale for reasons of safety or effectiveness before an 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