Mylan announced Thursday it has launched Medroxyprogesterone Acetate (MPA) Injectable Suspension USP, 150 mg/mL Single-Dose Vial in the United States for the prevention of pregnancy.
A new generic version of Pfizer's Depo-Provera® is being brought to the pharmaceutical market.1
Mylan announced Thursday it has launched Medroxyprogesterone Acetate (MPA) Injectable Suspension USP, 150 mg/mL Single-Dose Vial in the United States for the prevention of pregnancy.1 According to Pfizer, Depo-Provera CI is a progestin hormone birth control method that is given by injection.2
"The launch of Medroxyprogesterone Acetate adds to Mylan's robust portfolio of generic birth control medicines in the U.S. These products are part of Mylan's growing women's health care offerings, which include a variety of medicines to help women manage their health across all the stages of their lives," said Mylan CEO Heather Bresch, in a prepared statement.1
Women who use MPA may lose calcium and significant bone mineral density, according to Mylan and Pfizer. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of MPA during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. MPA should not be used longer than 2 years, unless other birth control methods are considered inadequate.1,2
An Abbreviated New Drug Application (ANDA) for Mylan's product was approved by the FDA. Mylan has 179 ANDAs pending FDA approval. Forty-four of these pending ANDAs are potential first-to-file opportunities, according to Mylan.1
Other generic MPA products compable to Depo-Provera include Teva Pharmacueticals' injectable suspension, 150 mg.3