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Fablyn FDA Approval Status

FDA Approved: No
Brand name: Fablyn
Generic name: lasofoxifene tartrate
Dosage form: Tablets
Previous Name: Oporia
Company: Pfizer Inc.
Treatment for: Osteoporosis

Fablyn (lasofoxifene tartrate) is a selective estrogen receptor modulator (SERM) intended for the treatment of osteoporosis in postmenopausal women.

In January 2009, Pfizer Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Fablyn (lasofoxifene tartrate) had not been approved.

Development timeline for Fablyn

Jul 24, 2013Ligand Signs License Agreement with Ethicor for Oral Lasofoxifene
Jan 20, 2009Pfizer Receives FDA Complete Response Letter for Lasofoxifene
Jan 16, 2008Ligand Partner Pfizer Submits NDA for Fablyn
Sep 13, 2005Pfizer Statement on Lasofoxifene

Further information

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