[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Notices]
[Pages 78606-78607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26932]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-2674]


Determination That CALAN SR (Verapamil Hydrochloride) Extended-
Release Oral Tablet, 180 Milligrams, Was Not Withdrawn From Sale for 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 or Agency) has 
determined that CALAN SR (verapamil hydrochloride) extended-release 
oral tablet, 180 milligrams (mg), was not withdrawn from sale for 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 verapamil 
hydrochloride extended-release oral tablet, 180 mg, if all other legal 
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.

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.
    CALAN SR (verapamil hydrochloride) extended-release oral tablet, 
180 mg, is the subject of NDA 019152 held by Pfizer Inc. CALAN SR is 
indicated for the treatment of hypertension, to lower blood pressure. 
CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 
mg, is currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book.
    Heritage Pharma Labs, Inc., submitted a citizen petition dated 
August 31, 2016 (Docket No. FDA-2016-P-2674), under 21 CFR 10.30, 
requesting that the Agency determine whether CALAN SR (verapamil 
hydrochloride) extended-release oral tablet, 180 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 CALAN SR (verapamil hydrochloride) 
extended-release oral tablet, 180 mg, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that CALAN SR (verapamil hydrochloride) 
extended-release oral tablet, 180 mg, was withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of CALAN SR (verapamil hydrochloride) 
extended-release oral tablet, 180 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 this drug product was withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list CALAN SR (verapamil 
hydrochloride) extended-release oral

[[Page 78607]]

tablet, 180 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 CALAN SR (verapamil hydrochloride) extended-release oral 
tablet, 180 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: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26932 Filed 11-7-16; 8:45 am]
 BILLING CODE 4164-01-P