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Strides Pharma receives USFDA approval for Fluoxetine tablets

Strides Pharma Science Ltd has received approval from the United States Food & Drug Administration (USFDA) for its Fluoxetine tabs in 10 mg and 20 mg strengths. The newly approved Fluoxetine tablets are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac tablets of Eli Lilly. 

The market size for Fluoxetine tablets is approximately $23.9 million, according to IMS. The company said this approval strengthens its presence in the Fluoxetine portfolio, which includes Fluoxetine capsules, with a market size of $106 million. The tablets will be manufactured at the company’s facility in Puducherry.

Strides Pharma has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 245 ANDAs have been approved. The company plans to launch approximately 60 new products over the next three years in the US.

Fluoxetine, an antidepressant of the Selective Serotonin Reuptake Inhibitor (SSRI) class, is used for the treatment of Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Bulimia Nervosa, Panic Disorder, with or without Agoraphobia.

However, the shares were down by 0.80 per cent at ₹838.80 at 11.32 am on the BSE. 

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