Drugs Pharma

USFDA grants ‘tentative approval’ to Zydus’ mental health drug

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HQ Team

January 16, 2023: The United States Food and Drug Administration (USFDA) has granted Zydus Lifesciences Limited ‘tentative approval’ to market Levomilnacipran extended-release capsules in the country, in 20 mg, 40 mg, 80 mg, and 120 mg dosages.

Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder (MDD) in adults, per a 16 January Zydus stock market statement

The drug will be manufactured at the pharma company’s formulations facility at Moraiya, Ahmedabad, India. 

Levomilnacipran Extended-Release Capsules had annual sales of USD85m in the US, according to IQVIA data (IQVIA MAT September 2022). 

Zydus also said it now has 341 approvals and has so far filed over 431 abbreviated new drug applications (ANDAs) since the commencement of the filing process in financial year (FY) 2003-04. 

According to the US regulator, an abbreviated new drug application (ANDA) contains data which is submitted to the FDA for the review and potential approval of a generic drug product. “Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.”

Zydus Lifesciences (formerly known as Cadila Healthcare Limited) has a market capitalisation of around INR443.9bn on the National Stock Exchange (NSE), where its stock has advanced some 22% to INR438.7 over the past six months.

Last week, Zydus told shareholders that the FDA had granted the company a ‘final approval’ to market Brexpiprazole tablets in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg dosages in the US.

Brexpiprazole is an “atypical antipsychotic” indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. It is also indicated for the treatment of schizophrenia in adults and pediatric patients ages 13 years and older. The tablets had annual sales of USD1,548m in the United States, according to IQVIA data (IQVIA MAT September 2022).ENDS//

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