Skip to Content

Fablyn 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 Status and FDA Approval Process 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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.