Strides Shasun receives US FDA approval for amantadine tablet

Strides Shasun has received approval from the US Food & Drug Administration (FDA) 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 $ 22 million with two generic players. The company plans to launch the product very soon.

Strides Shasun also recently announced US FDA approval for amantadine hydrochloride capsule and the combined market size of tablets and capsules is approximately $ 47 million.

Amantadine hydrochloride tablet is indicated for the treatment of Parkinson's disease and in the treatment of Shingles (herpes