October 1, 2018 / 11:08 AM / 15 days ago

Antares Pharma's testosterone drug gets FDA approval

Oct 1 (Reuters) - The U.S. Food and Drug Administration on Monday approved Antares Pharma Inc’s drug to treat low testosterone levels in men, the company said, nearly a year after rejecting the injection.

The drug, however, comes with a boxed warning - the FDA’s strongest - flagging risks of rise in blood pressure that can cause major cardiovascular events.

The FDA had declined to approve the drug, Xyosted, in October last year, highlighting elevated blood pressure, depression and suicidal tendencies in patients.

Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Arun Koyyur

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