[Federal Register Volume 89, Number 71 (Thursday, April 11, 2024)]
[Notices]
[Page 25632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07722]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-4587]
Determination That KEMSTRO (Baclofen) Orally Disintegrating
Tablets, 10 Milligrams and 20 Milligrams, Were Not Withdrawn From Sale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 KEMSTRO (baclofen) orally disintegrating tablets, 10
milligrams (mg) and 20 mg, were not withdrawn from sale for reasons of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 baclofen orally
disintegrating tablets, 10 mg and 20 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Alexander Poonai, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-9120, [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FDA determines that the listed drug was withdrawn from sale for reasons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.
KEMSTRO (baclofen) orally disintegrating tablets, 10 mg and 20 mg,
are the subject of NDA 021589, held by UCB, Inc., and initially
approved on October 30, 2003. KEMSTRO is indicated for the alleviation
of signs and symptoms of spasticity resulting from multiple sclerosis,
particularly for the relief of flexor spasms and concomitant pain,
clonus, and muscular rigidity.
KEMSTRO (baclofen) orally disintegrating tablets, 10 mg and 20 mg,
are currently listed in the ``Discontinued Drug Product List'' section
of the Orange Book.
Pharmobedient Consulting, LLC, submitted a citizen petition dated
October 16, 2023 (Docket No. FDA-2023-P-4587), under 21 CFR 10.30,
requesting that the Agency determine whether KEMSTRO (baclofen) orally
disintegrating tablets, 10 mg and 20 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 KEMSTRO (baclofen) orally disintegrating
tablets, 10 mg and 20 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that KEMSTRO (baclofen) orally disintegrating
tablets, 10 mg and 20 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of KEMSTRO (baclofen) orally disintegrating
tablets, 10 mg and 20 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 drug products were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list KEMSTRO (baclofen)
orally disintegrating tablets, 10 mg and 20 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 KEMSTRO (baclofen) orally
disintegrating tablets, 10 mg and 20 mg, may be approved by the Agency
so 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: April 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07722 Filed 4-10-24; 8:45 am]
BILLING CODE 4164-01-P