Alembic Pharmaceuticals 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 agnist indicated for the management of spasticity.
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.
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