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FDA Approves Pfizer�s Depo-subQ provera 104™

Pfizer Inc announced that it has received FDA approval for Depo-subQ provera 104™ (medroxyprogesterone acetate injectable suspension) for the management of pain associated with endometriosis, a gynecological condition that affects one in ten women of reproductive age. The medicine is the first new treatment option for endometriosis pain in 15 years.

Depo-subQ provera 104™ is a long-acting injectable contraception and a new formulation of medroxyprogesterone acetate, which is the same active ingredient as Depo-Proveraå Contraceptive Injection. Administered by subcutaneous injection four times a year, Depo-subQ provera 104™ is effective in halting menstruation, which results in thinner, more compact endometrial tissue. This in turn halts the growth of endometrial implants, relieving endometriosis-associated pain.

Clinical data showed that Depo-subQ provera 104™ is equally as effective for treating pain caused by endometriosis as leuprolide acetate (LA), marketed as Lupron Depotå, with significantly less decline in bone mineral density, and lower incidence and severity of menopausal symptoms, such as hot flashes.

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