Strides Pharma Secures US FDA Nod For Fluoxetine Tablets

Strides Pharma Science, an indian pharmaceutical firm, declared that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Ltd., Singapore, has acquired FDA approval for fluoxetine tabs in the 10 mg and 20 mg strengths. The product is bioequivalent and therapeutically equivalent to Eli Lilly's Reference Listed Drug (RLD), Prozac pills.

According to IMS, the market size for Fluoxetine tablets is approximately $23.9 million. This clearance enhances the company's position in the fluoxetine portfolio, complementing the previous approval of fluoxetine capsules, which has a market value of US$106 million. The fluoxetine tablets will be made at the company's facility in Puducherry.

The pharmaceutical company has 260 total ANDA submissions with the US FDA (including the newly acquired portfolio from Endo at Chestnut Ridge), of which 245 have been approved. Over the next three years, the business plans to launch over 60 new items in the US.

Fluoxetine is an antidepressant from the selective serotonin reuptake inhibitor (SSRI) class. It is used to treat major depressive disorder (MDD), obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorder, both with and without agoraphobia.

Strides Pharma Science Limited is an Indian pharmaceutical firm situated in Bangalore, southern India. The company makes pharmaceuticals, over-the-counter medications, and nutraceuticals. Products include softgel capsules, hardgel capsules, tablets, and dry and wet injectables. Its softgel manufacturing capability includes an annual capacity of 50,000 machine hours, or around three billion softgel capsules.