[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Tablets, 10 Milligrams and 20 Milligrams, Were Not Withdrawn From Sale 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milligrams (mg) and 20 mg, were not withdrawn from sale for reasons of 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