By a News Reporter-Staff News Editor at Clinical Trials Week -- Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) announced the reintroduction of the generic equivalent to Depo-Provera®1 Contraceptive Injection (medroxyprogesterone acetate injectable suspension, USP) 150 mg/mL, in the United States. Medroxyprogesterone acetate injectable suspension is a progestin indicated only for the prevention of pregnancy (see also Pharmaceutical Companies).
"This reintroduction brings an additional product to a market that was previously lacking in options," said Dr. Hafrun Fridriksdottir, Executive Vice President, President of Global Generics R&D. "In addition to its importance to patients who will benefit from access to this medicine, this reintroduction holds significant importance to Teva and our generics R&D priorities."
Teva has been committed to strengthening its generic injectable business globally, by making continued investment in newer, higher-value generic injectable products. With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Medroxyprogesterone acetate injectable suspension, USP 150 mg/mL had annual sales of approximately $211 million in the United States, according to IMS data as of July 2017. About Medroxyprogesterone Acetate Injectable Suspension, USP Medroxyprogesterone acetate injectable suspension is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use medroxyprogesterone acetate injectable suspension long-term. Important Safety InformationWomen who use medroxyprogesterone acetate injectable suspension may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. Medroxyprogesterone acetate injectable suspension should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate. The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: known or suspected pregnancy or as a diagnostic test for pregnancy; active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease; known or suspected malignancy of breast; known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients; significant liver disease; or undiagnosed vaginal bleeding.
Studies have shown an increased risk of breast cancer in women using medroxyprogesterone acetate injectable suspension. Serious thrombotic events; anaphylaxis and anaphylactoid reaction; injection site reactions; convulsions; weight gain; and decreased glucose tolerance have been reported with the use of medroxyprogesterone acetate injectable suspension.
In clinical trials the most common adverse reactions (incidence > 5%) were: menstrual irregularities (bleeding or spotting), abdominal pain/discomfort, dizziness, headache, nervousness, and decreased libido. Medroxyprogesterone acetate injectable suspension does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Keywords for this news article include: Antineoplastics, Pharmaceutical Companies, Teva Pharmaceutical Industries Ltd, Oncology, Progestins, Sex Hormones, Bone Research, Breast Cancer, Contraceptives, Drugs and Therapies, Risk and Prevention, Breast Ductal Carcinoma, Medroxyprogesterone Therapy.
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