Strides Shasun receives USFDA approval

8 Jun 2017

Strides Shasun today announced that it has received approval from the United States Food & Drug Administration (USFDA) for Amantadine Hydrochloride Capsules USP, 100 mg. The product received approval in 15 months under the new GDUFA regime.
According to IMS data, the US market for this product is approximately USD 25 million with three generic players. The product will be launched immediately.
Amantadine Hydrochloride Capsules are indicated for the treatment of Parkinson’s disease and in the treatment of Shingles (Herpes Zoster) to reduce pain. (EOIC)