USFDA approval granted for Topiramate ER Capsules

With this most recent USFDA approval, their tally of final Abbreviated New Drug Application (ANDA) approvals has reached an impressive 50.

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USFDA Approval

Last Updated on September 4, 2023 by The Health Master

USFDA approval

In an exciting development, Ajanta Pharma has recently obtained USFDA approval from the United States Food and Drug Administration (USFDA) for their groundbreaking product, the Topiramate Extended-Release Capsules, in varying strengths of 25 mg, 50 mg, 100 mg, and 200 mg.

This significant approval paves the way for Ajanta Pharma to bring this innovative medication to the market and offer potential benefits to patients in need.

Generic Innovation at its Best

Topiramate, now available in its generic form through Ajanta Pharma, stands as the counterpart to Supernus Pharmaceuticals Inc.’s well-known Trokendi XR.

This pharmaceutical advancement provides a more affordable alternative for consumers while maintaining the same level of quality and efficacy.

As part of the agreement reached with the original innovator, Ajanta Pharma is poised to introduce Topiramate to the market on or before February 1, 2026, with the possibility of an earlier launch under specific conditions.

Medicine capsule
Picture: Unsplash

Ajanta’s USFDA approval

With this most recent USFDA approval, their tally of final Abbreviated New Drug Application (ANDA) approvals has reached an impressive 50.

Out of these, 41 have already been successfully brought into commercialization, reflecting the company’s commitment to timely and effective product launches.

Additionally, Ajanta Pharma holds an additional two tentative approvals, signifying their proactive stance in seeking opportunities for further expansion and innovation.

Furthermore, 22 ANDAs await the crucial seal of approval from the USFDA, highlighting Ajanta’s continuous efforts to enrich their product portfolio and serve a wider range of medical needs.

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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