[Federal Register Volume 75, Number 129 (Wednesday, July 7, 2010)]
[Notices]
[Pages 39024-39025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16439]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES>

Food and Drug Administration

[Docket No. FDA-2010-P-0171]


Determination That ACCUTANE (Isotretinoin) Capsules, 10 
Milligrams, 20 Milligrams, and 40 Milligrams, Were Not Withdrawn From 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 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(mg), 20 mg, and 40 mg, were not withdrawn from sale for reasons of 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.

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.

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

[[Page 39025]]

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.
    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 Sec.  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.

    Dated: June 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16439 Filed 7-6-10; 8:45 am]
BILLING CODE 4160-01-S