FDA approves Antares Pharma's overactive bladder drug

Oxybutynin gel approved; Watson will launch under licensing agreement

PARSIPPANY, N.J. — The Food and Drug Administration has approved a topical gel made by Antares Pharma for overactive bladder.

Watson Pharmaceuticals announced Thursday the approval of oxybutynin gel in the 3% strength, which it will launch next year under a licensing agreement with Antares.

"This significant achievement represents Antares' first [new drug application] approval and is the culmination of a development program managed successfully by our clinical and regulatory team, Antares president and CEO Paul Wotton said. "Watson Pharmaceuticals proven track record of commercializing transdermal products to urologists and other significant prescribers of [overactive bladder] treatments makes them an ideal partner to execute a successful product launch."


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