Strides Pharma Gets U.S. FDA Nod For Amantadine Hydrochloride Softgel Capsules

Strides Pharma Science Ltd. announced that its subsidiary Strides Pharma Global, Singapore received final U.S. FDA approval for Amantadine Hydrochloride Softgel Capsules USP, 100 mg.

• This is bioequivalent and therapeutically equivalent to the reference listed drug, Symmetrel Capsules, 100 mg, of Endo Pharma.
• The drug is indicated for treatment of prophylaxis and symptoms of infection due to influenza A virus strains. The capsules are also used in the treatment of parkinsonism and drug-induces extrapyramidal reactions.
• According to IQVIA moving annual total December 2021 data, the U.S. market for the capsules is nearly $11 million. The combined market size of the Amantadine hydrochloride capsules and tablets is approximately $21 million.
• The capsules will be manufactured in Strides Pharma’s facility in Bengaluru.

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