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