Merck & Co. failed to win U.S. approval of an oral contraceptive already sold in Europe and a glaucoma treatment on the market in nine countries.
The U.S. Food and Drug Administration sent “complete response letters” earlier this month on the contraceptive NOMAC/E2, available in Europe under the name Zoely, and on tafluprost, sold abroad as Saflutan, according to a regulatory filing by Merck, the second-biggest U.S. drugmaker.
“The company plans to have further discussions with the FDA,” said Ronald Rogers, a spokesman for Whitehouse Station, New Jersey-based Merck, in a phone interview. “We are not getting into any of the specifics of what was in the letter.”
Merck plans to highlight the company’s research at a meeting of analysts tomorrow. The drugmaker is attempting to come up with new medicines to replace revenue that will be lost when its best-selling product, the asthma drug Singulair, faces generic competition next year.
Rogers said that both Zoely and Saflutan were “smaller products” and that the company doesn’t break out individual sales figures for them. Merck licensed rights to tafluprost in markets including the U.S. from Santen Pharmaceutical Co., a Japanese maker of eye drugs, in 2009.
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