New Delhi: Drug firm Strides Shasun has received the US health regulator’s nod for Amantadine Hydrochloride tablets, used in the treatment of Parkinson’s disease and Shingles to reduce pain.
“The product received approval in 15 months under the new GDUFA regime,” Strides Shasun said in a regulatory filing.
“Strides Shasun… has received approval from the USFDA for Amantadine Hydrochloride tablets 100 mg,” it said.
According to IMS data, the US market for this product is approximately $22 million (around Rs 141 crore) with two generic players. The product will be launched immediately.