[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42103-42104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18817]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-2496]


Determination That RITALIN LA (Methylphenidate Hydrochloride) 
Extended-Release Capsules, 60 Milligrams, Were Not Withdrawn From Sale 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 or Agency) has 
determined that RITALIN LA (methylphenidate hydrochloride) extended-
release capsules, 60 milligrams (mg), were not withdrawn from sale for 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 
methylphenidate hydrochloride extended-release capsules, 60 mg, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 240-
402-3543.

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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer 
to a listed drug.
    RITALIN LA (methylphenidate hydrochloride) extended-release 
capsules, 60 mg, are the subject of NDA 021284, held by Novartis 
Pharmaceuticals Corp. (Novartis) and initially approved on October 27, 
2014. RITALIN LA is indicated for the

[[Page 42104]]

treatment of Attention Deficit Hyperactivity Disorder (ADHD).
    In a letter dated March 23, 2016, Novartis notified FDA that 
RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 
60 mg, were being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Abhai, LLC, submitted a citizen petition dated April 19, 2017 
(Docket No. FDA-2017-P-2496), under 21 CFR 10.30, requesting that the 
Agency determine whether RITALIN LA (methylphenidate hydrochloride) 
extended-release capsules, 60 mg, were 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 RITALIN LA (methylphenidate 
hydrochloride) extended-release capsules, 60 mg, were not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that RITALIN LA (methylphenidate 
hydrochloride) extended-release capsules, 60 mg, were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of RITALIN LA 
(methylphenidate hydrochloride) extended-release capsules, 60 mg, from 
sale. We have also independently evaluated relevant literature and data 
for possible postmarketing adverse events. We have reviewed the 
available evidence and determined that this drug product was not 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list RITALIN LA 
(methylphenidate hydrochloride) extended-release capsules, 60 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 RITALIN LA 
(methylphenidate hydrochloride) extended-release capsules, 60 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: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18817 Filed 9-5-17; 8:45 am]
 BILLING CODE 4164-01-P