[Federal Register Volume 90, Number 103 (Friday, May 30, 2025)]
[Notices]
[Page 23056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09772]
[[Page 23056]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-0101]
Determination That COREG CR (Carvedilol Phosphate) Extended-
Release Capsules, 10 Milligrams, 20 Milligrams, 40 Milligrams, and 80
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or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, Agency, or we) has
determined that COREG CR (carvedilol phosphate) extended-release
capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 mg, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
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,
[email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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.
COREG CR (carvedilol phosphate) extended-release capsules, 10 mg,
20 mg, 40 mg, and 80 mg, are the subject of NDA 022012, held by Waylis
Therapeutics LLC, and initially approved on October 20, 2006. COREG CR
is an alpha-/beta-adrenergic blocking agent indicated for the treatment
of mild to severe chronic heart failure, left ventricular dysfunction
following myocardial infarction in clinically stable patients, and
hypertension.
COREG CR (carvedilol phosphate) extended-release capsules, 10 mg,
20 mg, 40 mg, and 80 mg, are currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
Amata Labs Ltd. submitted a citizen petition dated January 9, 2025
(Docket No. FDA-2025-P-0101), under 21 CFR 10.30, requesting that the
Agency determine whether COREG CR (carvedilol phosphate) extended-
release capsules, 10 mg, 20 mg, 40 mg, and 80 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 COREG CR (carvedilol phosphate) extended-
release capsules, 10 mg, 20 mg, 40 mg, and 80 mg, were not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that COREG CR (carvedilol
phosphate) extended-release capsules, 10 mg, 20 mg, 40 mg, and 80 mg,
were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
COREG CR (carvedilol phosphate) extended-release capsules, 10 mg, 20
mg, 40 mg, and 80 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 COREG CR (carvedilol
phosphate) extended-release capsules, 10 mg, 20 mg, 40 mg, and 80 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. FDA will not begin procedures to
withdraw approval of approved ANDAs that refer to these drug products.
Additional ANDAs for these drug products may also 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 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09772 Filed 5-29-25; 8:45 am]
BILLING CODE 4164-01-P