
[Federal Register: December 3, 2009 (Volume 74, Number 231)]
[Notices]               
[Page 63405-63406]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de09-30]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0560]

 
Determination That MESANTOIN (Mephenytoin) Tablets, 100 
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 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 MESANTOIN (mephenytoin) Tablets, 100 milligrams 
(mg), was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for mephenytoin tablets, 100 mg, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993-0002, 301-
796-3601.

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 
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.

[[Page 63406]]

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.
    Schiff & Co. submitted a citizen petition dated October 16, 2008 
(Docket No. FDA-2008-P-0560), under 21 CFR 10.30, requesting that the 
agency determine whether MESANTOIN (mephenytoin) Tablets, 100 mg, was 
withdrawn from sale for reasons of safety or effectiveness. MESANTOIN 
(mephenytoin) Tablets, 100 mg, is the subject of NDA 6-008, held by 
Novartis and initially approved on October 23, 1946. MESANTOIN is 
indicated to control grand mal, local, Jacksonian, and psychomotor 
seizures in patients who have been refractory to less toxic 
anticonvulsants. In a letter dated January 13, 2000, Novartis notified 
FDA that MESANTOIN (mephenytoin) Tablets, 100 mg, was being 
discontinued and FDA moved the drug product to the ``Discontinued Drug 
Product List'' section of the Orange Book.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that MESANTOIN (mephenytoin) Tablets, 100 mg, was not 
withdrawn from sale for reasons of safety or effectiveness. The 
petitioner identified no data or other information suggesting that 
MESANTOIN (mephenytoin) Tablets, 100 mg, was 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 MESANTOIN (mephenytoin) 
Tablets, 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 MESANTOIN (mephenytoin) Tablets, 100 mg, may be approved by 
the agency if all other legal and regulatory requirements for the 
approval of ANDAs are met. 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: November 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28872 Filed 12-2-09; 8:45 am]

BILLING CODE 4160-01-S
