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Alembic gets US FDA nod for Tizanidine hydrochloride capsules used to treat spasticity

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: Alembic

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Drug firm Alembic Pharmaceuticals said it has received final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity. “The company has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg,” the drug firm said in a regulatory filing.

Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important.

“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. Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 111 ANDA approval — 99 final approvals and 12 tentative approvals — from US FDA. The shares of Alembic Pharmaceuticals Ltd were trading at Rs 573, up 1.96 per cent on BSE in morning trade.

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