Strides Shasun Receives USFDA Approval For Amantadine Hydrochloride Tablets


Stride Shasun on Monday announced that it has received approval from the United States Food & Drug Administration (USFDA) for Amantanide Hydrochloride tablets 100 mg. The product received approval in 15 months under the new GDUFA regime.

According to the 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 USFDA approval for Amantanide Hydrochloride capsules and the combine market size of tablets and capsules is approximately USD 47 million.

Amantanide Hydrochloride tablets are indicated for the treatment of Parkinson’s disease and in the treatment of Shingles (Herpes Zoster) to reduce pain.

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