The UK Medicines and Healthcare products Regulatory Agency (UK MHRA) has granted Dr. Reddy laboratories(UK) Ltd, a subsidiary of Dr. Reddy laboratories got marketing authorization for the Risedronate Sodium 5 mg and 35 mg tablets.
It was originally developed and marketed by the Warner Chilcott under the brand name drug Actonel. It is indicative for the treatment of postmenopausal osteoporosis. According to Warner Chilcott annual report Actonel has annual sales of US$ 221 million for the 12 months ended December 2009.
For the US Market, Teva Pharmaceuticals already received the final approval for the Abbreviated New Drug Application(ANDA) from the US Food and Drug Administration (FDA).