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Notice

Determination That ACCUTANE (Isotretinoin) Capsules, 10 Milligrams, 20 Milligrams, and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing its determination that ACCUTANE (isotretinoin) Capsules, 10 milligrams (mg), 20 mg, and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

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FOR FURTHER INFORMATION CONTACT:

Olivia Pritzlaff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-796-3506.

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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 Start Printed Page 39025versions 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.

ACCUTANE (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg, are the subject of NDA 18-662, held by Hoffman-La Roche, Inc. (Roche), and initially approved on May 7, 1982. ACCUTANE is indicated for the treatment of severe recalcitrant nodular acne. In a letter dated June 24, 2009, Roche notified FDA that ACCUTANE (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg, were being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book. There are three approved ANDAs for isotretinoin capsules; these are listed in the Orange Book and, following the discontinuation of ACCUTANE, one of them was designated as the listed drug to which new ANDAs should refer.

Sun Pharmaceutical Industries, Inc., submitted a citizen petition dated March 22, 2010 (Docket No. FDA-2010-P-0171), under 21 CFR 10.30, requesting that the agency determine whether ACCUTANE (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg, were withdrawn from sale for reasons of safety or effectiveness.

FDA has reviewed its records and, under § 314.161, has determined that ACCUTANE (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that ACCUTANE (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg, were 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 ACCUTANE (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg, 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.

FDA will not begin procedures to withdraw approval of approved ANDAs that refer to ACCUTANE. Additional ANDAs for isotretinoin capsules may also be approved by the agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for isotretinoin capsules should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling.

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Dated: June 30, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-16439 Filed 7-6-10; 8:45 am]

BILLING CODE 4160-01-S