News
14 Nov 2011
Merck Receives Two FDA Rejections
Merck has received two rejections from the US FDA. The company plans to discuss the rejections with the FDA.
US pharma giant Merck has received two rejections from the US FDA, 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.
The company then received the second rejection 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.
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