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Strides Shasun receives US FDA approval for amantadine HCl tablets

Our Bureau, Bengaluru
Monday, June 12, 2017, 15:15 Hrs  [IST]

Strides Shasun has received approval from the United States 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 US$ 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 US$ 47 million.
 
Amantadine hydrochloride tablets are indicated for the treatment of Parkinsons’s disease and in the treatment of Shignles (Herpes Zoster) to reduce pain.

 

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