Last Updated on October 11, 2024 by The Health Master
USFDA approval
In a significant stride towards advancing healthcare solutions, Strides Pharma Science Ltd. has garnered USFDA approval from the United States Food and Drug Administration (USFDA) for Icosapent Ethyl capsules.
This achievement is attributed to the relentless efforts of Strides Pharma Global Pte Limited, Singapore, a wholly-owned subsidiary of Strides Pharma. Let’s delve into the details of this approval and its implications.
Icosapent Ethyl Capsules: A Breakthrough in Cardiovascular Health
Overview:
- Icosapent Ethyl Capsules, in doses of 0.5 gram and 1 gram, have been granted the green light by the USFDA.
- These capsules are hailed as bioequivalent and therapeutically equivalent to the reference-listed drug (RLD), Vascepa of Amarin®, a noteworthy benchmark in the industry.
- Market research firm IQVIA estimates the market size for Icosapent Ethyl Capsules to be a substantial $1.3 billion.
Manufacturing Hub:
- The capsules will be manufactured at Strides Pharma‘s state-of-the-art facility in Bengaluru, showcasing the company’s commitment to quality and innovation.
Strides Pharma’s Proven Track Record:
- The company boasts an impressive track record, with 260 cumulative ANDA filings, including the recently acquired portfolio from Endo at Chestnut Ridge.
- Among these, an impressive 230+ ANDAs have been successfully approved.
- With an eye on the future, Strides Pharma has set an ambitious target to launch approximately 60 new products in the US market over the next three years.
Icosapent Ethyl Capsule: Enhancing Cardiovascular Health
Indications and Usage:
- Icosapent Ethyl Capsule is a prescription medication prescribed in conjunction with other medicines, such as statins.
- Its primary goal is to significantly reduce the risk of heart attack, stroke, and other cardiovascular issues in individuals grappling with cardiovascular disease.
Recent Triumphs in HIV Treatment
Groundbreaking NDA approval:
- Strides Pharma achieved yet another milestone this month with tentative USFDA approval for its New Drug Application (NDA) 505b2 of Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumarate 50mg/ 300mg/ 300mg tablets.
A Beacon of Hope for HIV Patients:
- This comprehensive regimen offers a beacon of hope for those afflicted by HIV-1 infection, both in the adult and pediatric patient populations weighing at least 35 kilograms.
Easing the Burden of Chronic Kidney Disease
Approval for Sevelamer Carbonate:
- Strides Pharma’s relentless pursuit of innovative solutions also led to USFDA approval for Sevelamer Carbonate for Oral Suspension USP, available in 0.8gm and 2.4gm doses.
Addressing Elevated Phosphate Levels:
- This medication addresses a critical concern in patients with chronic kidney disease, effectively managing elevated phosphate levels in the bloodstream.
Market Potential:
- The combined market potential for Sevelamer carbonate tablets and oral suspension is estimated to be a noteworthy ~$212 million, as per IQVIA.
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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