[Federal Register Volume 86, Number 95 (Wednesday, May 19, 2021)]
[Notices]
[Pages 27092-27093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10552]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-P-2244 and FDA-2020-P-2245]


Determination That ISOPTIN (Verapamil Hydrochloride) Tablets 40 
Milligrams, 80 Milligrams, and 120 Milligrams, and CALAN (Verapamil 
Hydrochloride) Tablets, 40 Milligrams, 80 Milligrams, 120 Milligrams, 
and 160 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety 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, Agency, or we) has 
determined that ISOPTIN (verapamil hydrochloride) tablets, 40 
milligrams (mg), 80 mg, and 120 mg, and CALAN (verapamil hydrochloride) 
tablets, 40 mg, 80 mg, 120 mg, and 160 mg, were not withdrawn from sale 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 ISOPTIN 
(verapamil hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN 
(verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601, [email protected].

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.
    ISOPTIN (verapamil hydrochloride) tablets, 40 mg, 80 mg, and 120 
mg, are the subject of NDA 018593, held by Mt. Adams Technologies, LLC, 
and initially approved on March 8, 1982. CALAN (verapamil 
hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, are the 
subject of NDA 018817, held by Pfizer Inc., and initially approved on 
September 10, 1984. ISOPTIN and CALAN are indicated for the treatment 
of angina, arrythmias, and essential hypertension.
    Center Laboratories, Inc., submitted two citizen petitions dated 
November 30, 2020 (Docket Nos. FDA-2020-P-2244 and FDA-2020-P-2245), 
under 21 CFR 10.30, requesting that the Agency determine whether 
ISOPTIN (verapamil hydrochloride) tablets, 40 mg, 80 mg,

[[Page 27093]]

and 120 mg, and CALAN (verapamil hydrochloride) tablets, 40 mg, 80 mg, 
120 mg, and 160 mg, were withdrawn from sale for reasons of safety or 
effectiveness.
    After considering the citizen petitions and reviewing Agency 
records and based on the information we have at this time, FDA has 
determined under Sec.  314.161 that ISOPTIN (verapamil hydrochloride) 
tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil hydrochloride) 
tablets, 40 mg, 80 mg, 120 mg, and 160 mg, were not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that ISOPTIN (verapamil 
hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil 
hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, were 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of ISOPTIN 
(verapamil hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN 
(verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 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 these drug products were not 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list ISOPTIN (verapamil 
hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil 
hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 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 ISOPTIN (verapamil 
hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil 
hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 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: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10552 Filed 5-18-21; 8:45 am]
BILLING CODE 4164-01-P