Merck (NYSE: MRK) has received complete letters from the US Food and Drug Administration for an oral contraceptive and eye treatment drug it markets in non-US countries it disclosed in a filing with the Securities and Exchange Commission, an indication that the FDA has declined to approve the drugs, according to Reuters.
The Whitehouse Station, New Jersey pharmaceutical company’s oral contraceptive Nomac/E2 is sold in Europe as Zoely and its glaucoma treatment drug, tafluprost, is sold in nine countries. It licensed the rights to tafluprost from Japanese drugmaker Santen Pharamaceutical Co.
A Merck spokesman told Bloomberg: “’The company plans to have further discussions with the FDA. We are not getting into any of the specifics of what was in the letter.’
The company is also discontinuing the clinical development program for MK-0431C, a diabetes treatment that combines sitagliptin and pioglitazone, a move “based on a review of the regulatory and commercial prospects for the combination drug candidate,” the filing said.
In July Merck received a complete response letter from the FDA for its drug Janumet XR, an extended release version of its diabetes drug Janumet, tied to “pre-approval inspection issues,” according to the SEC filing. Merck said that it has responded to the questions raised by the US regulator and expects a response in the first quarter of 2012.
Separately, the FDA approved Merck’s single-rod hormonal contraceptive, Nexplanon. The device is inserted in a woman’s arm beneath the skin to prevent pregnancy for up to three years.