FDA rejects Pfizer's new osteoporosis therapy

The FDA has turned thumbs down on Pfizer's new osteoporosis treatment Oporia. Pfizer declined to say what reasons the agency gave for the non-approvable letter, saying that they were proprietary. But Pfizer said it would study the response before determining how it might proceed with the treatment. Oporia is a selective estrogen receptor modulator, or SERM, which is designed to enhance the positive aspects of hormones while suppressing negative attributes. Pfizer originally submitted its NDA in August of last year and followed up with an application for Oporia as a treatment for vaginal atrophy.

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PLUS: Pfizer did win European approval for Aromasin as a treatment for breast cancer. Release