Alembic gets FDA green light for 2 generics

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Alembic gets FDA green light for 2 generics

By Sandra Levy - 07/15/2019
Alembic has received the Food and Drug Administration’s clearance for two new generic drugs.

Approval was received for its clonazepam orally disintegrating tablets in dosage strengths of 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg.

The product is the generic of Hoffmann-LaRoche’s Clonopin orally disintegrating tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg.

It is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam orally disintegrating tablets may be useful. It also is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSMV.

Clonazepam orally disintegrating tablets had a market value of about $20 million for the 12 months ended December 2018, according to IQVIA.

Alembic also received the FDA’s approval for febuxostat tablets in dosage strengths of 40 mg and 80 mg.

The product is the generic of Takeda’s Uloric tablets 40 mg and 80 mg.

Febuxostat tablets are an xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment wLth allopurinol is not advisable.

Febuxostat tablets had a market value of roughly $578 million for the 12 months ended December 2018, according to IQVIA.

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