FDA Spurns Merck & Co., Inc. Contraceptive, Glaucoma Drug

The Food and Drug Administration has declined to approve an oral contraceptive and a glaucoma treatment being developed by Merck & Co Inc, but the drugmaker did not disclose details of the agency’s concerns. Merck already sells both products in some overseas markets. The contraceptive, called NOMAC/E2, is a pill that combines two hormones. The glaucoma medicine, tafluprost, is also known by its brand name Saflutan. Merck buried mention of the two setbacks in a 62-page regulatory filing with the Securities and Exchange Commission, saying it received so-called complete response letters from the FDA for both products.

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