Industry

USFDA approval granted for Icosapent Ethyl Capsules

Of these, an impressive 230+ ANDAs have successfully navigated the rigorous USFDA approval process under the vigilant scrutiny of the USFDA.

The Health Master

October 3, 2023

USFDA Drug product Approval — USFDA Approval

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Last Updated on December 24, 2023 by The Health Master

USFDA approval

In a significant stride towards expanding its global footprint, Strides Pharma Science proudly announced on September 23, 2023, that its subsidiary, Strides Pharma Global Pte in Singapore, has received the coveted USFDA approval for Icosapent Ethyl Capsules, both in 0.5 gram and 1 gram variants, from the esteemed United States Food & Drug Administration (USFDA).

This groundbreaking development serves to bolster Strides’ existing repertoire of approved soft gelatin capsules, marking a promising addition to their pharmaceutical offerings.

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Bioequivalence Triumph

The Icosapent Ethyl Capsules stand as a beacon of bioequivalence and therapeutic equivalence in comparison to the Reference Listed Drug (RLD), Vascepa, developed by Amarin.

This USFDA approval is poised to carve out a substantial niche within the pharmaceutical market, with the product boasting an estimated market size of an impressive $1.3 billion, as reported by IQVIA.

The manufacturing hub for this innovative product will be Strides’ state-of-the-art facility in Bengaluru, further solidifying their commitment to cutting-edge pharmaceutical production.

Stellar Portfolio and Ambitious Projections

With a staggering 260 cumulative ANDA filings, inclusive of the recently acquired Endo portfolio at Chestnut Ridge, Strides Pharma stands tall in its pursuit of excellence.

Of these, an impressive 230+ ANDAs have successfully navigated the rigorous USFDA approval process under the vigilant scrutiny of the USFDA.

Undeterred by their already remarkable track record, the company has set its sights on an ambitious target: the launch of approximately 60 new products over the next three years in the United States.

Insights into the USFDA Drug Approval Process

1. Regulatory Affairs Consulting:

Essential for navigating the complex landscape of USFDA approvals.
Ensures adherence to stringent regulatory guidelines.

2. USFDA Drug Approval Process:

A meticulous process involving rigorous evaluation of safety and efficacy.
Demands comprehensive documentation and compliance with USFDA standards.

3. Generic Drug Approval Pathway:

An economical alternative to brand-name drugs, requiring a robust Abbreviated New Drug Application (ANDA).
Necessitates a thorough demonstration of bioequivalence.

4. FDA Expedited Programs:

Designed to accelerate the approval process for drugs addressing unmet medical needs.
Includes Fast Track Designation, Breakthrough Therapy Designation, Priority Review Process, and Accelerated Approval Process.

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