Industry

USFDA Approval granted for Generic Sevelamer Carbonate Oral Suspension

Strides Pharma Science announced that the USFDA has granted USFDA approval for Sevelamer Carbonate oral suspension in two strengths: 0.8g and 2.4g.

The Health Master

September 10, 2023

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Last Updated on October 9, 2024 by The Health Master

USFDA Approval

Strides Pharma Science Ltd., through its subsidiary Strides Pharma Global Pte Ltd Singapore, has achieved a significant milestone with USFDA approval from the US Food & Drug Administration (USFDA) for its generic Sevelamer Carbonate oral suspension.

This development is poised to revolutionize the treatment of chronic kidney disease in patients undergoing dialysis, preventing dangerous spikes in phosphate levels.

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Key Details:

USFDA Approval for Multiple Strengths:

Strides Pharma Science announced that the USFDA has granted USFDA approval for Sevelamer Carbonate oral suspension in two strengths: 0.8g and 2.4g.

Equivalent to Renvela:

The newly approved product is both bioequivalent and therapeutically equivalent to the reference-listed drug, Renvela for Oral Suspension, in its 0.8g and 2.4g variants.

This endorsement attests to the quality and efficacy of Strides‘ formulation.

Completing the Sevelamer Carbonate Portfolio:

With this approval, Strides has successfully rounded off its Sevelamer Carbonate product line.

Notably, this achievement is particularly significant as the product is classified as a complex generic, an area with a limited number of market players offering both tablet and oral suspension versions.

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Manufacturing Hub in Bengaluru:

The approved Sevelamer Carbonate oral suspension will be produced at Strides‘ state-of-the-art facility in Bengaluru, reinforcing the company’s commitment to maintaining high manufacturing standards.

Market Potential:

According to data from IQVIA, the combined market opportunity for Sevelamer Carbonate in both tablet and oral suspension forms is estimated at a substantial USD 212 million.

This indicates a robust demand for the product, which Strides is now poised to meet.

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. USFDA 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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