Merck & Co has had two products, an oral contraceptive and a glaucoma drug, rejected by the US Food and Drug Administration.
The news was disclosed in a regulatory filing with the US Securities and Exchange Commission for the third quarter, and not through the usual channel of a news release. On page 54 of the 62-page filing, the US major notes that in the last week it has received two complete response letters from the FDA.
On November 4, the FDA turned down a marketing application for NOMAC/E2 (nomegestrol acetate/estradiol), an oral contraceptive which is being marketed as Zoely in Europe by partner Teva. Three days later, the FDA issued a CRL for tafluprost, a treatment for glaucoma and ocular hypertension which is sold outside the USA as Saflutan/Taflotan and was licensed from Japan’s Santen Pharmaceutical Co.
Merck is saying little about the rejections and states that the company plans to have further discussions with the FDA with regard to the letters. However, it did issue a release to note that it has launched its implanted contraceptive Nexplanon (etonogestrel) in the USA.
The filing also revealed that Merck is discontinuing the clinical development programme for MK-0431C, a combination of the firm’s Januvia (sitagliptin) and Takeda’s Actos (pioglitazone) for the treatment of diabetes. The company added that the decision is “based on a review of the regulatory and commercial prospects for the combination drug candidate”.
Later today, Merck is holding its 2011 R&D and business briefing.
