Strides Pharma Gains FDA Approval for Generic Fluoxetine 60mg Tablets
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Strides Pharma has received FDA approval for its generic Fluoxetine 60mg tablets, expanding its portfolio of this antidepressant drug.
The approval allows Strides Pharma to offer a complete range of Fluoxetine products, including 10mg, 20mg, and 60mg tablets and capsules.
Fluoxetine capsules and tablets have a combined market size of $130 million, offering a substantial commercial opportunity for Strides Pharma.
Strides Pharma Science has secured FDA approval for its generic Fluoxetine 60mg tablets, enabling the company to broaden its offerings of this antidepressant medication. The approval allows Strides Pharma to provide a comprehensive portfolio of Fluoxetine products, encompassing capsules and tablets in 10mg, 20mg, and 60mg dosages. The company previously received FDA approval for Fluoxetine 10mg and 20mg tablets, as well as capsules, in April.
The market for Fluoxetine capsules and tablets is valued at $130 million, according to Intercontinental Medical Statistics. The introduction of Fluoxetine 60mg tablets will provide enhanced dosing flexibility, catering to a wider range of patient needs. Strides Pharma intends to launch all three tablet strengths in the near future, with manufacturing taking place at its facility in Puducherry.
According to a company statement, "The addition of the Fluoxetine Tabs 60 mg will allow for enhanced flexibility in dosing, catering to a broader spectrum of patient needs. The company plans to launch all three strengths in the near future."
Strides Pharma maintains its US sales guidance of $285–300 million for the current year and $400 million by fiscal year 2027. The company aims to file two niche products (controlled substance or nasal spray), each with a market size of $600–700 million, with the FDA by the first quarter of next year.