Sun Pharmaceutical Industries Ltd. announced that US FDA has granted a tentative approval for an Abbreviated New Drug Application (ANDA) a generic version of Boniva, Ibandronate Sodium Injection, 1 mg(base)/ml, packaged in 3 ml Single-dose Vials.

This generic Ibandronate Sodium Injection, equivalent to Roche’s Boniva Injection, 1 mg(base)/ml. Annual sale in US is approximately $ 70 million. Ibandronate Sodium Injection is indicated in the treatment of osteoporosis in postmenopausal women. Boniva is a registered trademark of Hoffmann-La Roche Inc.

Sun Pharmaceutical Industries Ltd. is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.