Strides Shasun receives USFDA approval

12 Jun 2017

Strides Shasun today announced that it has received approval from the United States Food & Drug Administration (USFDA) for Amantadine Hydrochloride Tablets 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 22 Million with two generic players. The product will be launched immediately.
The Company also recently announced US FDA approval for Amantadine Hydrochloride Capsules and the combined market size of Tablets and Capsules is approximately USD 47 Million. (EOIC)