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November 10, 2011

Merck hit by double FDA rejection

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.

By Liam Stoker

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.

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.

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