Pfizer Submits NDA for Osteoporosis Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer has submitted a NDA to the FDA for Fablyn (lasofoxifene tartrate) Tablets (formerly, Oporia), a selective estrogen receptor modulator (SERM) for the treatment of osteoporosis in postmenopausal women. Pfizer included three-year interim data from the Postmenopausal Evaluation And Risk-reduction with Lasofoxifene (PEARL) study in the current NDA to support its NDA for lasofoxifene in the treatment of osteoporosis.     Pfizer is developing the drug with Ligand Pharmaceuticals Inc. The two ...

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