[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55796-55797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22807]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0157]


Determination That VESANOID (Tretinoin) Capsules, 10 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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) has determined that 
VESANOID (tretinoin) Capsules, 10 milligrams (mg), were not withdrawn 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 the 
abbreviated new drug application (ANDA) that refers to this drug 
product, 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:  Molly Flannery, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6237, Silver Spring, MD 20993-0002, 301-
796-3543.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-

[[Page 55797]]

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.
    VESANOID (tretinoin) Capsules, 10 mg, are the subject of NDA 20-
438, held by Hoffman-La Roche Inc. (Roche), and initially approved on 
November 22, 1995. VESANOID is indicated for the ``induction of 
remission in patients with acute promyelocytic leukemia (APL), French-
American-British (FAB) classification M3 (including the M3 variant), 
characterized by the presence of the t(15;17) translocation and/or the 
presence of the PML/RAR[agr] [promyelocytic leukemia/retinoic acid 
receptor alpha] gene who are refractory to, or who have relapsed from, 
anthracycline chemotherapy, or for whom anthracycline-based 
chemotherapy is contraindicated'' (VESANOID labeling).
    In a letter dated December 2, 2009, Roche notified FDA that 
VESANOID (tretinoin) Capsules, 10 mg, were being discontinued, and FDA 
moved the drug product to the ``Discontinued Drug Product List'' 
section of the Orange Book. There is one approved ANDA for tretinoin 
capsules, 10 mg (ANDA No. 77-684); this drug product is listed in the 
Orange Book and, following the discontinuation of VESANOID, was 
designated as the reference listed drug to which new ANDAs should 
refer.
    Rakoczy Molino Mazzochi Siwik LLP submitted a citizen petition 
dated March 17, 2010 (Docket No. FDA-2010-P-0157), under 21 CFR 10.30, 
requesting that the agency determine whether VESANOID (tretinoin) 
Capsules, 10 mg, were withdrawn from sale for reasons of safety or 
effectiveness.
    After considering the citizen petition and reviewing agency 
records, FDA has determined under Sec.  314.161 that VESANOID 
(tretinoin) Capsules, 10 mg, were not withdrawn for reasons of safety 
or effectiveness. The petitioner has identified no data or other 
information suggesting that VESANOID (tretinoin) Capsules, 10 mg, were 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of VESANOID 
(tretinoin) Capsules, 10 mg, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events and have 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 VESANOID (tretinoin) 
Capsules, 10 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 the approved ANDA that refers 
to VESANOID. Additional ANDAs for tretinoin capsules, 10 mg, may also 
be approved by the agency as long as they meet all other legal and 
regulatory requirements for the approval of ANDAs. 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: September 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22807 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S