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Intrinsa Approval Status

FDA Approved: No
Brand name: Intrinsa
Generic name: testosterone
Dosage form: Patch
Company: BioSante Pharmaceuticals, Inc.
Treatment for: Female Sexual Dysfunction

Intrinsa (testosterone transdermal patch) is an androgen intended for use in the treatment of female sexual dysfunction (FSD) in surgically menopausal women.

In December 2004, BioSante Pharmaceuticals, Inc. announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Intrinsa had not been approved.

Development Status and FDA Approval Process for Intrinsa

DateArticle
Dec  3, 2004BioSante Pharmaceuticals Comments on FDA Advisory Committee's Decision Not to Recommend Approval of Testosterone Patch

Further information

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