Document ID: FDA-2022-N-1999-0001
Agency: fda
Document Type: Notice
Title: Merck Sharp & Dohme Corp.; Withdrawal of Approval of New Drug Applications for VIOXX (Rofecoxib)
Tablets and Suspension
Posted Date: 2022-09-13T04:00Z

[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56061-56062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19740]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1999]

Merck Sharp & Dohme Corp.; Withdrawal of Approval of New Drug 
Applications for VIOXX (Rofecoxib) Tablets and Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of the new drug applications (NDAs) for VIOXX 
(rofecoxib) Tablets, 12.5 milligrams (mg), 25 mg, and 50 mg, and VIOXX 
(rofecoxib) Suspension, 12.5 mg/5 milliliter (mL) and 25 mg/5 mL, held 
by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., P.O. 
Box 100, 1 Merck Dr., Whitehouse Station, NJ 08889 (Merck). Merck has 
voluntarily requested that FDA withdraw approval of these applications 
and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of September 13, 2022.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and

[[Page 56062]]

Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, 
Silver Spring, MD 20993-0002, 301-796-3137, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA approved VIOXX (rofecoxib) Tablets (NDA 
21042 and NDA 21647) and VIOXX (rofecoxib) Suspension (NDA 21052) for 
the following indications:
     For relief of the signs and symptoms of osteoarthritis.
     For relief of the signs and symptoms of rheumatoid 
arthritis in adults.
     For relief of the signs and symptoms of pauciarticular or 
polyarticular course juvenile rheumatoid arthritis in patients 2 years 
and older and who weigh 10 kg (22 lbs) or more.
     For the management of acute pain in adults.
     For the treatment of primary dysmenorrhea.
     For the acute treatment of migraine attacks with or 
without aura in adults.
    On September 27, 2004, Merck informed the Agency it had halted the 
Adenomatous Polyp Prevention on VIOXX (APPROVe) trial due to an 
increased relative risk for confirmed cardiovascular events, such as 
heart attack and stroke, beginning after 18 months of treatment in 
patients taking VIOXX (rofecoxib) compared to those taking placebo. On 
September 30, 2004, Merck voluntarily withdrew VIOXX from the U.S. 
market. In early 2005, FDA conducted a comprehensive review of the 
approved cyclooxygenase-2 (COX-2) selective and non-selective non-
steroidal anti-inflammatory drugs (NSAIDs) and the risk of adverse 
cardiovascular events. On April 6, 2005, after holding a joint meeting 
of the Arthritis and Drug Safety and Risk Management Advisory 
Committees, FDA issued a decisional memorandum summarizing the Agency's 
analysis and recommendations regarding the NSAIDs that were the subject 
of the review (https://www.fda.gov/media/74279/download). In that 
report, FDA made various recommendations, including modifications to 
the safety information in the labeling of approved COX-2 selective 
NSAIDs, including VIOXX. On June 3, 2005, Merck subsequently requested 
FDA's input on the content of potential supplemental NDAs to support 
labeling changes, in the event that Merck decided to bring the drug 
back to the U.S. market. On December 12, 2005, FDA identified certain 
safety analyses and other information that would be required in support 
of such supplemental NDAs.
    In Merck's letter requesting withdrawal of VIOXX, Merck summarized 
its views of the reasons for withdrawal of approval as follows. Merck 
ultimately made a business decision not to recommence distribution of 
VIOXX in the United States and, therefore, did not conduct the 
additional analyses or submit supplemental NDAs supporting the 
reintroduction of VIOXX. In light of the company's commercial decision 
not to reintroduce VIOXX to the U.S. market, Merck has requested that 
FDA withdraw approval of NDA 21042, NDA 21052, and NDA 21647 for VIOXX 
tablets and suspension.
    FDA has determined that withdrawal of these NDAs under Sec.  
314.150(d) (21 CFR 314.150(d)) is appropriate, because Merck did not 
provide the additional information necessary to reintroduce VIOXX 
(rofecoxib) to the U.S. market that FDA requested in its December 12, 
2005, correspondence. On October 7, 2021, Merck requested that FDA 
withdraw approval of NDA 21042, NDA 21052, and NDA 21647 for VIOXX 
(rofecoxib) under Sec.  314.150(d) and waived its opportunity for a 
hearing.
    For the reasons discussed above, and in accordance with the 
applicant's request, approval of NDA 21042 and NDA 21647 for VIOXX 
(rofecoxib) Tablets, 12.5 mg, 25 mg, and 50 mg, and NDA 21052 for VIOXX 
(rofecoxib) Suspension, 12.5 mg/5 mL and 25 mg/5 mL, and all amendments 
and supplements thereto, are withdrawn under Sec.  314.150(d). 
Distribution of VIOXX (rofecoxib) Tablets, 12.5 mg, 25 mg, and 50 mg, 
and VIOXX (rofecoxib) Suspension, 12.5 mg/5 mL and 25 mg/5 mL, 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 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19740 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P