[Federal Register Volume 78, Number 129 (Friday, July 5, 2013)]
[Notices]
[Pages 40484-40485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0303]
Determination That METADATE ER (Methylphenidate Hydrochloride)
Extended-Release Tablet, 10 Milligrams, Was Not Withdrawn From Sale for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) has determined that
METADATE ER (methylphenidate hydrochloride (HCl)) extended-release
tablet, 10 milligrams (mg), was not withdrawn from sale for reasons of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 methylphenidate HCl
extended-release tablet, 10 mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Reena Raman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6238, Silver Spring, MD 20993-0002, 301-
796-7577.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products 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 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drug was withdrawn from sale for reasons of safety or effectiveness (21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).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
METADATE ER (methylphenidate HCl) extended-release tablet, 10 mg,
is the subject of ANDA 40-306, held by UCB, Inc., and initially
approved on October 20, 1999. METADATE ER is indicated as an integral
part of a total treatment program which typically includes other
remedial measures (psychological, educational, social) for a
stabilizing effect in children with a behavioral syndrome characterized
by the following group of developmentally inappropriate symptoms:
Moderate-to-severe distractibility, short attention span,
hyperactivity, emotional lability, and impulsivity.
In a letter dated November 4, 2011, UCB, Inc., notified FDA that
METADATE ER (methylphenidate HCl) extended-release tablet, 10 mg, had
been discontinued, and FDA moved the drug product to the ``Discontinued
Drug Product List'' section of the Orange Book.
Tedor Pharma Inc. submitted a citizen petition dated March 6, 2013
(Docket No. FDA-2013-P-0303), under 21 CFR 10.30, requesting that the
Agency determine whether METADATE ER (methylphenidate HCl) extended-
release tablet, 10 mg, was withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that METADATE ER (methylphenidate HCl) extended-
release tablet, 10 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that METADATE ER (methylphenidate HCl) extended-
release tablet, 10 mg, was withdrawn for
[[Page 40485]]
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of this product from sale.
We have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We 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 METADATE ER
(methylphenidate HCl) extended-release tablet, 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. ANDAs that refer to METADATE ER
(methylphenidate HCl) extended-release tablet, 10 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 this drug product should be revised to meet current standards, the
Agency will advise ANDA applicants to submit such labeling.
Dated: June 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16101 Filed 7-3-13; 8:45 am]
BILLING CODE 4160-01-P