Alembic gets USFDA nod for Tizanidine HCL capsules

"The company has received final approval from the US Food & Drug Administration (USFDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg,"

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Alembic gets USFDA nod for Tizanidine hydrochloride capsules used to treat spasticity

New Delhi: 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 (USFDA) 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.

Also read: Alembic gets USFDA nod for Vilazodone HCL Tab

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.

Also read: Also read: USFDA approves Merck’s Keytruda for bladder cancer

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