Last Updated on December 22, 2024 by The Health Master
USFDA approval
Strides Pharma Science, a leading pharmaceutical company, has received a significant approval from the US Food and Drug Administration (USFDA) for its subsidiary, Strides Pharma Global Pte.
The approval pertains to Fluoxetine Tablets in 10mg and 20mg dosages, a generic version of Eli Lilly’s well-known antidepressant medication, Prozac.
This is a major win for Strides as it expands their presence in the lucrative Fluoxetine market and increases access to affordable treatment options for patients in the United States.
Fluoxetine Tablets: A Cost-Effective Solution for Millions
The US market for Fluoxetine tablets is estimated at around $23.9 million, presenting a substantial opportunity for Strides.
This approval complements their existing portfolio, which already includes Fluoxetine capsules with a market size of $106 million.
By offering a generic alternative, Strides can help bring down treatment costs and improve access for patients struggling with depression and other mental health conditions.
Strides Strengthens US Presence with Robust ANDA Pipeline
The USFDA approval for Fluoxetine tablets underscores Strides Pharma’s commitment to the American market.
The company boasts a robust pipeline with over 260 ANDA (Abbreviated New Drug Application) filings with the USFDA, including recent acquisitions.
Notably, 245 ANDAs have already been approved, demonstrating their successful track record.
To further solidify their US presence, Strides has set an ambitious target of launching approximately 60 new products within the next three years.
Fluoxetine: A Versatile Medication for Mental Health
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) belonging to a widely prescribed class of antidepressants. It plays a crucial role in managing various mental health conditions, including:
- Major depressive disorder (MDD)
- Obsessive-compulsive disorder (OCD)
- Bulimia nervosa
- Panic disorder, with or without agoraphobia
By receiving USFDA approval for Fluoxetine tablets, Strides Pharma Science is well-positioned to make a significant contribution to improving mental healthcare affordability and accessibility in the United States.
This approval broadens treatment options for patients and reinforces Strides’ commitment to delivering high-quality generic medications.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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