[Federal Register Volume 85, Number 181 (Thursday, September 17, 2020)]
[Notices]
[Pages 58063-58064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2020-N-1735]


Eisai, Inc.; Withdrawal of Approval of Two New Drug Application 
for BELVIQ (lorcaserin hydrochloride) and BELVIQ XR (lorcaserin 
hydrocholoride)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
approval of two new drug applications for BELVIQ (lorcaserin 
hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended-
release tablets held by Eisai, Inc., 155 Tice Blvd., Woodcliff Lake, NJ 
07677 (Eisai). Eisai requested withdrawal of these applications and has 
waived its opportunity for a hearing.

DATES: Approval is withdrawn as of September 17, 2020.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: FDA approved NDA 022529 for BELVIQ 
(lorcaserin HCl) 10 milligrams (mg) tablets and NDA 208524 for BELVIQ 
XR (lorcaserin HCl) 20 mg extended-release tablets on June 27, 2012 and 
July 15, 2016, respectively, as an adjunct to a reduced-calorie diet 
and increased physical activity for chronic weight management in adults 
with an initial body mass index (BMI) of:
     30 kg/m\2\ or greater (obese) or
     27 kg/m2 or greater (overweight) in the presence of at 
least one weight-related comorbid condition, (e.g., hypertension, 
dyslipidemia, type 2 diabetes).
    On January 14, 2019, FDA issued a Drug Safety Communication 
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 because a safety clinical trial showed 
an increased occurrence of cancer (see

[[Page 58064]]

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 requested that FDA withdraw approval of 
NDA 022529 for BELVIQ and NDA 208524 for BELVIQ XR under Sec.  
314.150(d) (21 CFR 314.150(d)), and waived its opportunity for a 
hearing.
    For the reasons discussed above, and pursuant to the applicant's 
request, approval of NDA 022529 BELVIQ (lorcaserin HCl) tablets and 
208524 BELVIQ XR (lorcaserin HCl) extended-release tablets, and all 
amendments and supplements thereto, are withdrawn under Sec.  
314.150(d). Distribution of BELVIQ into interstate commerce without an 
approved application is illegal and subject to regulatory action (see 
sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(a) and 331(d)).

    Dated: September 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20458 Filed 9-16-20; 8:45 am]
BILLING CODE 4164-01-P