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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]

# 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and Drug Administration (FDA) is announcing its determination that DOVONEX (calcipotriene) Ointment, 0.005%, was not withdrawn from sale for reasons of safety or effectiveness.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                               ( print 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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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 § 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 § 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