The product will be launched immediately
Strides Shasun has received approval from the US health regulator for Amantadine Hydrochloride, used for the treatment of Parkinsons disease and select viral infections, in the US market.
“The product has received approval in 15 months under the USFDA’s new product clearance regime of GDUFA. The product will be launched immediately,” Strides Shasun said in a BSE filing.
Amantadine Hydrochloride is used for the treatment of Parkinsons disease and Shingles (Herpes Zoster) to reduce pain.
Quoting IMS data, Strides Shasun said the US market for Amantadine Hydrochloride is approximately $25 million with three generic players.