Dec 31 2010
SUN PHARMA.
Sun Pharma announces USFDA tentative approval for generic Boniva Sun Pharmaceutical Industries has announced that USFDA 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 US$ 70 million. Ibandronate Sodium Injection is indicated in the treatment of osteoporosis in postmenopausal women.The company made this announcement after the trading hours on 30 December 2010.