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Ahmedabad-based Zydus Lifesciences Ltd. has received tentative approval from the United States Food and Drug Administration (USFDA) for Levomilnacipran extended-release capsules.

The company’s subsidiary Zydus Pharmaceuticals (USA) Inc (Zydus) will market Levomilnacipran extended-release capsules of 20 mg, 40 mg, 80 mg, and 120 mg.

Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI) used for the treatment of major depressive disorder (MDD) in adults. Zydus will manufacture the drug at its formulation manufacturing facility at Moraiya in Ahmedabad.

The estimated annual sales of Levomilnacipran extended-release capsules were $85 million in the US market for the 12 months ending in September 2022, according to IQVIA data.

Recently, Zydus Lifesciences received final approval and 180 days of shared exclusivity from the USFDA for Brexpiprazole Tablets.

Zydus was one of the first applicants to submit a substantially complete abbreviated new drug application (ANDA) with a paragraph IV certification for Brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4mg. Brexpiprazole is used to treat certain mental conditions in adults.

Earlier this month, the pharma major launched Topiramate Extended-Release Capsules in the US market through its subsidiary Zydus Pharmaceuticals (USA) Inc. for the treatment of epilepsy. Topiramate capsules are used in patients 6 years and older with partial onset, primary generalised tonic-clonic seizures, or seizures associated with Lenox-Gastaut Syndrome (LGS).

The Zydus Lifesciences stock ended 0.75 percent lower at Rs 438.05 on Monday.

(Edited by : Rukmani Krishna)