Strides Shasun gets USFDA nod for pain relieving drug
New Delhi: Drug firm Strides Shasun Ltd has received the US health regulator, US Food and Drug Administration’s (USFDA) 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 on Monday. “Strides Shasun... has received approval from the USFDA for Amantadine Hydrochloride tablets 100mg,” it said.
According to IMS data, the US market for this product is approximately $22 million (around Rs141 crore) with two generic players. The product will be launched immediately.
Shares of the company were trading 1.93% lower at Rs924.10 apiece on BSE.