[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Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons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were not withdrawn from sale for reasons of safety or effectiveness.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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