Strides Shasun gets USFDA approval for Parkinson’s drug
Strides Shasun has received approval from USFDA for Amantadine Hydrochloride, used for the treatment of Parkinson’s disease in the US market
New Delhi: Strides Shasun on Thursday said it has received approval from the US health regulator, Food and Drug Administration (FDA), for Amantadine Hydrochloride, used for the treatment of Parkinson’s disease and select viral infections, in the American 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 Parkinson’s 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.
Shares of the company were trading 2.29% higher at Rs958 on BSE.