
[Federal Register Volume 78, Number 129 (Friday, July 5, 2013)]
[Notices]
[Pages 40484-40485]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16101]


-----------------------------------------------------------------------

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Extended-Release Tablet, 10 Milligrams, Was Not Withdrawn From Sale for 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.

-----------------------------------------------------------------------

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tablet, 10 milligrams (mg), was not withdrawn from sale for reasons of 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


