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Alembic gets USFDA nod for capsules used to treat spasticity

IBEF:  January 16, 2020

Drug firm Alembic Pharmaceuticals has received final nod from the US health regulator for Tizanidine hydrochloride capsules, which is used to treat spasticity.

"The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," according to the drug firm’s regulatory filing.

Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity.

The treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important as the therapeutic effect is of short duration.

"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said.

The market size for Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg is estimated to be around US$ 28 million for twelve months ending September 2019 according to IQVIA.

Currently, Alembic has a cumulative total of 111 ANDA approval out of which 99 have received final approvals and 12 with tentative approvals from USFDA.

The shares of Alembic Pharmaceuticals Ltd were trading at Rs 573 (US$ 8.19), up 1.96 per cent on BSE in morning trade.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.