Strides Pharma Gains FDA Nod for Generic Fluoxetine

The US Food and Drug Administration approved Strides Pharma Science Ltd.'s generic version of the antidepressant medication fluoxetine. A business statement on Monday stated that Strides Pharma Global Pte., Singapore, the step-down fully owned subsidiary, received the approval.

The medication is therapeutically and bioequivalent to the reference mentioned medication, 60-milligram tablets of fluoxetine manufactured by Taiwan-based TWi Pharmaceuticals Inc. Bioequivalent and therapeutically equivalent simply mean generic medication. An antidepressant belonging to the selective serotonin reuptake inhibitor class, fluoxetine is prescribed for the management of panic disorder, major depressive disorder, bulimia nervosa, obsessive-compulsive disorder, and agoraphobia.

According to American healthcare information and services supplier Intercontinental Medical Statistics, the market for fluoxetine pills and capsules is valued at $130 million. "By adding the Fluoxetine Tabs 60 mg, dosage flexibility will be improved and a wider range of patient demands will be met. All three strengths will soon be released by the corporation, according to the announcement. The Puducherry plant of the generic medication manufacturer located in Bengaluru will produce fluoxetine tablets.

The management has stuck to its $285–300 million US sales projection for the current year and $400 million by the next fiscal year, 2027. Strides Pharma plans to submit two speciality goods (controlled substance or nasal spray) by the first quarter of the next year. These medicines would have a market value of $600–700 million apiece.