Aurobindo Pharma gets USFDA nod for Fluoxetine tablets

Aurobindo Pharma on Thursday said it has received the final approval from US Food and Drug Administration (USFDA) to manufacture and market Fluoxetine Tablets, 10 mg and 20 mg.

The product will be launched in April 2020. Fluoxetine tablets are generic version of Eli Lilly’s Prozac tablets and indicated for the acute and maintenance treatment of major depressive disorder.

The approved product has an estimated market size of $42 million for the twelve months ended February 2020, the company said citing IQVIA figures.

This is the first Abbreviated New Drug Application (ANDA) to be approved out of APL Healthcare formulation facility in Hyderabad. The facility is used for manufacturing oral products, a release from Aurobindo Pharma said.

A letter from the Editor

Dear reader,

We have been keeping you up-to-date with information on the developments in India and the world that have a bearing on our health and wellbeing, our lives and livelihoods, during these difficult times. To enable wide dissemination of news that is in public interest, we have increased the number of articles that can be read free, and extended free trial periods. However, we have a request for those who can afford to subscribe: please do. As we fight disinformation and misinformation, and keep apace with the happenings, we need to commit greater resources to news gathering operations. We promise to deliver quality journalism that stays away from vested interest and political propaganda.

Support Quality Journalism
Recommended for you
This article is closed for comments.
Please Email the Editor

Printable version | Jun 2, 2020 3:08:47 PM |

Next Story