[Federal Register Volume 86, Number 41 (Thursday, March 4, 2021)]
[Notices]
[Pages 12697-12698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04449]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0030]
Determination That BELVIQ (Lorcaserin Hydrochloride) Tablets, 10
Milligrams, and BELVIQ XR (Lorcaserin Hydrochloride) Extended-Release
Tablets, 20 Milligrams, Were Withdrawn From Sale for Reasons of Safety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 BELVIQ (lorcaserin hydrochloride) tablets, 10
milligrams (mg), and BELVIQ XR (lorcaserin hydrochloride) extended-
release tablets, 20 mg, were withdrawn from sale for reasons of safety
or effectiveness. The Agency will not accept or approve abbreviated new
drug applications (ANDAs) for lorcaserin hydrochloride tablets, 10 mg
and 20 mg.
FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6216, Silver Spring, MD 20993-0002, 240-
402-9674, Sungjoon.Chi@fda.hhs.gov.
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 seek approval to market a generic version of a previously
approved drug product. In general, to obtain approval, the ANDA
applicant must show, among other things, that the generic drug product
has the same active ingredient(s); dosage form; route of
administration; strength; conditions of use; and, with certain
exceptions, labeling as the listed drug. In addition, the ANDA
applicant must show that the generic drug product is bioequivalent to
the listed drug.
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 new drug application (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withdrawn from sale for reasons of safety or effectiveness (21 CFR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.
BELVIQ (lorcaserin hydrochloride) tablets, 10 mg, is the subject of
NDA 022529, and BELVIQ XR (lorcaserin hydrochloride) extended-release
tablets, 20 mg, is the subject of NDA 208524, both held by Eisai Inc.
(Eisai), and initially approved on June 27, 2012, and July 15, 2016,
respectively. BELVIQ and BELVIQ XR are indicated as an adjunct to a
reduced-calorie diet and increased physical activity for chronic weight
management in adults with an initial body mass index of:
30 kilograms per square meter (kg/m\2\) or greater
(obese); or
27 kg/m\2\ or greater (overweight) in the presence of at
least one weight-related comorbid condition (e.g., hypertension,
dyslipidemia, type 2 diabetes).
After reviewing Agency records and based on the information we have
at this time, FDA has determined under Sec. 314.161 that BELVIQ
(lorcaserin hydrochloride) tablets, 10 mg, and BELVIQ XR (lorcaserin
hydrochloride) extended-release tablets, 20 mg, were withdrawn for
reasons of safety or effectiveness.
In 2012, the Agency required the drug manufacturer to conduct a
randomized, double-blind, placebo-controlled clinical trial to evaluate
the risk of cardiovascular problems. The Cardiovascular and Metabolic
Effects of Lorcaserin in Overweight and Obese Patients--Thrombolysis in
Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial was
conducted to fulfill this requirement. An analysis of the CAMELLIA-TIMI
61 trial results suggests an imbalance in cancer in humans. Although
chance effect cannot be ruled out, the imbalance persisted throughout
multiple analysis approaches. The clinical findings corroborated by the
evidence from the animal models informed the Agency's assessment that
the risk outweighs any potential benefits for the current indications.
These findings were considered clinically meaningful and could not be
adequately addressed through labeling. Additional evidence would be
necessary to investigate this signal; however, the Agency has
determined that it is unlikely that the necessary safety endpoints
(i.e., cancer and reproductive safety) can be readily or ethically
investigated in a clinical trial. Because preclinical or clinical
studies would first need to be conducted to address these concerns, the
Agency has determined that this drug product would not be considered
safe and effective if it were reintroduced to the market.
FDA issued a Drug Safety Communication on January 14, 2020,
alerting the public that results from a clinical trial assessing the
risk of heart-related problems show a possible increased risk of cancer
with BELVIQ and BELVIQ XR (see https://www.fda.gov/drugs/drug-safety-and-availability/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr). On February 13, 2020,
FDA announced it had asked Eisai to voluntarily withdraw BELVIQ and
BELVIQ XR from the U.S. market (see https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market). On February 13, 2020, Eisai
submitted a request to FDA to withdraw approval of NDA 022529 for
BELVIQ and NDA 208524 for BELVIQ XR under 21 CFR 314.150(d) and waived
its opportunity for a hearing. As requested by Eisai, the Agency issued
a Federal Register notice on September 17, 2020 (85 FR 58063),
withdrawing approval of the
[[Page 12698]]
applications for BELVIQ (lorcaserin hydrochloride) tablets, 10 mg, and
BELVIQ XR (lorcaserin hydrochloride) extended-release tablets, 20 mg,
effective September 17, 2020.
Accordingly, the Agency will remove BELVIQ (lorcaserin
hydrochloride) tablets, 10 mg, and BELVIQ XR (lorcaserin hydrochloride)
extended-release tablets, 20 mg, from the list of drug products
published in the Orange Book. FDA will not accept or approve ANDAs that
refer to this drug product.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04449 Filed 3-3-21; 8:45 am]
BILLING CODE 4164-01-P