FDA WARNING_LETTER - Merck Sharp and Dohme Corp. - June 15, 2011

This FDA Warning Letter, Ref: 12-HFD-47-02-01, dated February 17, 2012, addresses Merck Sharp and Dohme Corp. for failing to comply with milestone dates for a required postmarketing study (PMR) concerning Januvia® and Janumet® (NDAs 021995 and 022044). The PMR was mandated to investigate a serious risk signal of acute pancreatitis, including necrotizing forms, associated with sitagliptin use.

The violation stems from noncompliance with a previously agreed-upon timetable for PMRs 1602 and 1603, specifically missing the June 15, 2010, final protocol submission and June 15, 2011, final report submission dates. Merck's attempt to satisfy the PMR with an independently conducted, investigator-initiated study was deemed insufficient as its protocol was not FDA-reviewed or agreed upon prior to initiation, and a final study report was not provided.

The FDA determined Merck failed to demonstrate good cause for these delays, which were over 20 months for protocol submission and over 8 months for the final report. This noncompliance violates section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, rendering the product misbranded under section 502(z).

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