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.

- read this story from MSN for more

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

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today.

Suggested Articles

Polyphor is developing an inhaled version of murepavadin, which targets Pseudomonas aeruginosa infections, but is currently given intravenously.

Japanese pharma Astellas is looking to offload a series of unwanted research projects ahead of Thanksgiving; if you want one, it’s made it very easy.

A re-engineered adenovirus prolonged survival in mouse models of metastatic lung cancer and cleared tumors in about 35% of the animals.