Aurobindo Pharma receives FDA approval for three generics Posted 12/06/2020

India-based generics maker Aurobindo Pharma (Aurobindo) has received three approvals from the US Food and Drug Administration (FDA) in recent months, including for its generic versions of guaifenesin, fluoxetine and – via partner company Eugia Pharma – methotrexate.

Aurobindo is headquartered in Hyderabad, India. The company specializes in generic drugs and active pharmaceutical ingredients (APIs). In recent months, it has received several product approvals from FDA.

In October 2019, the company received FDA approval for generic guaifenesin tablets. Guaifenesin is a cough medicine used for more than 60 years which may be combined with a cough suppressant, such as dextromethorphan. It works by loosening phlegm to help clear the bronchial passageways. First approved by FDA in 1952, an extended release version was approved in 2002.

Aurobindo’s version is of the extended release form and will be available in two doses (600 mg and 1,200 mg). The product is expected to launch in the fourth quarter of financial year (FY) 2020.

At the end of January 2020, Aurobindo received approval for generic methotrexate tablets via its joint venture company, Eugia Pharma Specialities Ltd, which is also based in India.

Methotrexate is an immunosuppressant indicated for the treatment of cancer, autoimmune disease and ectopic pregnancies. It can be administered by mouth or injection. Eugia received FDA approval for 2.5 mg tablets of methotrexate. The drug had an estimated market size of US$98 million in 2019.

Finally, in April 2020 it was reported that Aurobindo won FDA approval for generic fluoxetine tablets in two doses (10 mg and 20 mg). Fluoxetine, better known as Prozac, is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It was first discovered by Eli Lilly in 1972 and approved by FDA in 1987. At their peak, worldwide sales of the drug reached US$2.6 billion.

Indications for fluoxetine include major depressive disorder, obsessive compulsive disorder (OCD) and eating disorders. The drug has a market size estimated at US$42 million for the 12 months ending February 2020.

The abbreviated new drug application (ANDA) for fluoxetine is Aurobindo’s first to be approved out of its APL Healthcare formulation facility in Hyderabad, which is used for manufacturing oral products. In total, the firm now has 424 approved ANDAs (28 tentative) from FDA.

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Source: Aurobindo Pharma

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