USFDA nods to Strides Pharma's Amantadine Hydrochloride Softgel Capsules

21 Feb 2022 , 08:56 AM

In its press release on Monday, Strides Pharma Science Limited announced that its significant arm Strides Pharma Global Pte. Limited, Singapore, has bagged the approval for Amantadine Hydrochloride Softgel Capsules USP,100 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Symmetrel Capsules, 100 mg, of Endo Pharmaceuticals, Inc (Endo).

According to IQVIA MAT December 2021 data, the US market for Amantadine Hydrochloride Capsules USP,100 mg is approximately US$ 11 Mn. The company will manufacture this product at its facility situated in Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

The company also has approval for Amantadine Hydrochloride tablets and the combined market size of Tablets and Capsules together is approximately US$ 21 Mn as per IQVIA MAT December 2021 data.

The company has 271 cumulative ANDA filings with USFDA of which 244 ANDAs have been approved and 27 are pending approval.

Amantadine hydrochloride capsules are useful for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also known to cure parkinsonism and drug-induced extrapyramidal reactions.

On Friday, Strides Pharma ended at Rs364.90 down by Rs6.4 or 1.72% from its previous closing of Rs371.30 on the BSE.