FDA declines to approve Contrave

SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.

Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.

The FDA issues a complete response letter when it has finished reviewing the regulatory application for a drug, but questions remain that preclude final approval. In this case, the agency had concerns about cardiovascular safety risks in patients using the drug over the long term. The FDA said the companies must conduct a trial of “sufficient size and duration” to show that the cardiovascular risks of the drug don’t outweigh its benefits.

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