USFDA Gives Approval to Strides Shasun for Launching Amantadine Hydrochloride tablets

Shital Jibhe / 12 Jun 2017

USFDA Gives Approval to Strides Shasun for Launching Amantadine Hydrochloride tablets

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

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

The US market for this product approximately is USD 22 million with two generic players, according to the IMS data. The product will be launched immediately.

Apart from the Amantanide Hydrochloride tablets, the company also recently announced USFDA approval for Amantanide Hydrochloride capsules and the combined market size of tablets and capsules is approximately USD 47 million.

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

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