Aurobindo Pharma gains post ANDA approval

The shares of Aurobindo Pharma Limited (APL) were trading in green on Thursday after the company announced that it has received final approval from US Food and Drug Administration (USFDA) to manufacture and market Fluoxetine Tablets, 10 mg and 20 mg.

The approved drug is to be launched in April 2020 and is a generic version of Eli Lilly’s Prozac tablets. It has an estimated market size of US$ 42 million for the twelve-month ending February 2020, according to IMS Health and Quintiles (IQVIA)

Fluoxetine is indicated for the treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years. It can also help to treat obsessive-compulsive disorder (OCD) and treatment of binge-eating and vomiting behaviours in adult patients along with moderate to severe bulimia nervosa.

This is the first abbreviated new drug application (ANDA) to be approved out of APL healthcare formulation facility in Hyderabad (India) used for manufacturing oral products. The company now has a total of 424 ANDA approvals (396 final approvals including 22 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

Aurobindo Pharma Limited is a pharmaceutical company engaged in producing oral and injectable generic formulations and active pharmaceutical ingredients (APIs).

On Thursday, the stock closed at Rs 460.05, up by 4.97 per cent or Rs 21.80 per share. The 52-week high is recorded at Rs 838 and the 52-week low is Rs 281.15 on BSE.