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.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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.

Pharmaceutical Technology Excellence Awards - Nominations Closed

Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.

Excellence in Action
Imagene’s Oncology Intelligence (OI) Suite has won the Innovation Award for Precision Oncology, for transforming how pharma designs and runs oncology trials. From AI-driven biomarker discovery to smarter patient stratification, see how Imagene is cutting time, cost and risk in cancer drug development.

Discover the Impact