Israeli-based Teva Pharmaceutical Industries has launched new generic oral contraceptive Rajani in the US.
Rajani is the generic equivalent of Beyaz, which can be used by women to prevent pregnancy and treat symptoms of premenstrual dysphoric disorder (PMDD) in case they select an oral contraceptive.
Available in a 28-day blister pack dispenser, the drug can also be used to treat moderate acne vulgaris for women who are at least 14 years old.
Furthermore, Rajani will help raise folate levels in women for the purpose of reducing the risk of a neural tube defect in a pregnancy.
Teva said the new product will improve the company’s oral contraceptive portfolio.
Rajani does not protect against HIV infection (AIDS) and other sexually transmitted diseases and its effectiveness for PMDD when used for more than three menstrual cycles has not been assessed.
This product has not been evaluated for the treatment of premenstrual syndrome (PMS) and should be used to treat acne only if the patient desires an oral contraceptive for birth control.
Based on data published by IMS as of July this year, Beyaz had annual sales of approximately $133 million in the US.
Teva has a large portfolio of FDA-approved generic products on the market and more than 300 product registrations are pending FDA approval.
One in six generic prescriptions dispensed in the US are currently filled with a Teva generic product.