US-based pharmaceutical company Merck has been hit by a double rejection from the US Food and Drug Administration, the company confirmed through a regulatory filing with the US Securities and Exchange Commission.
The FDA turned down a marketing application for Merck’s contraceptive NOMAC/E2, better known as Zoely, despite Teva successfully marketing the drug in Europe.
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Merck then suffered a second blow as the FDA issued a Complete Response Letter for its glaucoma treatment tafluprost, which is sold by Santen Pharmaceutical as Saflutan/Taflotan outside of the US.
Merck plans to discuss the rejections with the FDA.
