Notice2022-19740
Merck Sharp & Dohme Corp.; Withdrawal of Approval of New Drug Applications for VIOXX (Rofecoxib) Tablets and Suspension
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 176 (Tuesday, September 13, 2022)</title>
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[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56061-56062]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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DATES: Approval is withdrawn as of September 13, 2022.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,
<a href="/cdn-cgi/l/email-protection#eca785818e899e8095c2a089849e8a898088ac8a888dc284849fc28b839a"><span class="__cf_email__" data-cfemail="703b191d1215021c095e3c15180216151c14301614115e1818035e171f06">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA approved VIOXX (rofecoxib) Tablets (NDA
21042 and NDA 21647) and VIOXX (rofecoxib) Suspension (NDA 21052) for
the following indications:
<bullet> For relief of the signs and symptoms of osteoarthritis.
<bullet> For relief of the signs and symptoms of rheumatoid
arthritis in adults.
<bullet> 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.
<bullet> For the management of acute pain in adults.
<bullet> For the treatment of primary dysmenorrhea.
<bullet> 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 (<a href="https://www.fda.gov/media/74279/download">https://www.fda.gov/media/74279/download</a>). 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
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