[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66742-66743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0631]


Determination That MOBAN (Molindone Hydrochloride) Tablets (5 
Milligrams, 10 Milligrams, 25 Milligrams, 50 Milligrams, and 100 
Milligrams) and Capsules (5 Milligrams, 10 Milligrams, and 25 
Milligrams) Were Not Withdrawn From Sale for Reasons of Safety or 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 
MOBAN (molindone hydrochloride (HCl)) tablets (5 milligrams (mg), 10 
mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 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were not withdrawn from sale for reasons of safety or effectiveness.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 MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 
mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 301-
796-3381.

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.
    MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 
mg) and capsules (5 mg, 10 mg, and 25 mg) are the subject of NDA 
017111, held by Endo Pharmaceuticals, and initially approved on January 
18, 1974. MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 
100 mg) and capsules (5 mg, 10 mg, and 25 mg) are indicated for the 
management of schizophrenia. MOBAN (molindone HCl) tablets (5 mg, 10 
mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) are 
currently listed in the ``Discontinued Drug Product List'' section of 
the Orange Book.
    CorePharma, LLC, submitted a citizen petition dated May 22, 2013 
(Docket No. FDA-2013-P-0631), under 21 CFR 10.30, requesting that the 
Agency determine whether MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 
mg, 50 mg, and 100 mg) were withdrawn from sale for reasons of safety 
or effectiveness. Although the citizen petition did not address MOBAN 
(molindone HCl) capsules (5 mg, 10 mg, and 25 mg), that dosage form has 
also been discontinued, and on our own initiative, we have also 
determined that MOBAN (molindone HCl) capsules (5 mg, 10 mg, and 25 mg) 
were not withdrawn for safety or effectiveness reasons.
    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 MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 
mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) were not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that MOBAN 
(molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) and 
capsules

[[Page 66743]]

(5 mg, 10 mg, and 25 mg) were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of MOBAN (molindone HCl) tablets (5 mg, 10 
mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) 
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 these products were withdrawn from 
sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list MOBAN (molindone HCl) 
tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 
mg, and 25 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 
MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) 
or capsules (5 mg, 10 mg, and 25 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: October 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26550 Filed 11-5-13; 8:45 am]
BILLING CODE 4160-01-P