[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76017-76018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0275]


Determination That GLEEVEC (Imatinib Mesylate) Capsules, 50 
Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons 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 
GLEEVEC (imatinib mesylate) Capsules, 50 milligrams (mg) and 100 mg, 
were not withdrawn from sale for reasons of safety or effectiveness. 
This determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for imatinib mesylate capsules, 50 mg and 100 mg, 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Rochelle Chodock Fink, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6236, Silver Spring, MD 20993-0002, 301-
796-0838.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term

[[Page 76018]]

Restoration Act of 1984 (Pub. L. 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.
    GLEEVEC (imatinib mesylate) Capsules, 50 mg and 100 mg, are the 
subject of NDA 21-335, held by Novartis Pharmaceutical Corp., and 
initially approved on May 10, 2001. GLEEVEC is a protein-tyrosine 
kinase inhibitor used in the treatment of a variety of malignancies, 
including Ph+ chronic myeloid leukemia and acute lymphoblastic 
leukemia, myelodysplastic/myeloproliferative diseases, aggressive 
systemic mastocytosis, hypereosinophilic syndrome, chronic eosinophilic 
leukemia, dermatofibrosarcoma protuberans, and gastrointestinal stromal 
tumors. FDA has moved GLEEVEC (imatinib mesylate) Capsules, 50 mg and 
100 mg, to the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Hyman, Phelps & McNamara, PC, submitted a citizen petition dated 
June 3, 2010 (Docket No. FDA-2010-P-0275), under 21 CFR 10.30, 
requesting that the Agency determine whether GLEEVEC (imatinib 
mesylate) Capsules, 50 mg and 100 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 GLEEVEC (imatinib 
mesylate) Capsules, 50 mg and 100 mg were not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that GLEEVEC (imatinib mesylate) Capsules, 50 mg 
and 100 mg, were withdrawn for reasons of safety or effectiveness. We 
have carefully reviewed our files for records concerning the withdrawal 
of GLEEVEC (imatinib mesylate) capsules, 50 mg and 100 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 these products were withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list GLEEVEC (imatinib 
mesylate) Capsules, 50 mg and 100 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. ANDAs that refer to GLEEVEC (imatinib mesylate) 
Capsules, 50 mg and 100 mg, may 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 these drug products 
should be revised to meet current standards, the Agency will advise 
ANDA applicants to submit such labeling.

    Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30570 Filed 12-6-10; 8:45 am]
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