Last Updated : Wednesday, January 15, 2020 14:33:47

ALEMBIC PHARMA gets USFDA nod to market anti-spasm drug

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered Indian pharmaceutical major – Alembic Pharmaceuticals Ltd said of having got approval to market anti-spasm (muscle contraction) drug.

The release titled, “Alembic Pharmaceuticals announces USFDA Final Approval for Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg”, further read that, Alembic Pharmaceuticals Limited (Alembic) today announced that 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.

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 B.V. 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.

Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of US$ 28 million for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 111 ANDA approvals (99 final approvals and 12 tentative approvals) from USFDA.

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