USFDA Approval: USFDA Approval granted for Apremilast Tablets

Furthermore, the company is on the cusp of achieving USFDA approval for an additional 50 Abbreviated New Drug Applications (ANDAs) from the USFDA.

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USFDA Approval

Last Updated on October 19, 2023 by The Health Master

USFDA Approval

In a significant stride towards enhancing its presence in the pharmaceutical market, Glenmark Pharmaceuticals has garnered final USFDA approval from the United States Food & Drug Administration (USFDA) for Apremilast Tablets.

These tablets are available in three strengths – 10 mg, 20 mg, and 30 mg, and represent the generic version of Amgen’s Otezla Tablets in the same strengths.

A Game-Changing Market Entry

IQVIA Sales Data: A Window into Success

The IQVIA sales data for the 12-month period culminating in August 2023 has shed light on the immense potential of Apremilast Tablets.

The market for Otezla Tablets, ranging from 10 mg to 30 mg, witnessed an astounding achievement with annual sales amounting to a staggering $3.7 billion.

This monumental figure signifies the demand and trust placed in this line of medication.

Glenmark’s Impressive Portfolio

Current Market Presence and Future Prospects

Currently, Glenmark boasts a portfolio comprising a diverse range of 188 products that are authorized for distribution within the US marketplace.

Furthermore, the company is on the cusp of achieving USFDA approval for an additional 50 Abbreviated New Drug Applications (ANDAs) from the USFDA.

This impending approval underscores Glenmark’s relentless pursuit of excellence in the pharmaceutical domain.

Apremilast Tablets: Pioneering Generic Drug Manufacturing

Revolutionizing Drug Production

The approval of Apremilast Tablets by the USFDA heralds a new era in generic drug manufacturing.

Glenmark’s success in creating a generic version of Amgen’s Otezla Tablets not only exemplifies their proficiency in this field but also signifies a breakthrough in providing affordable alternatives to critical medications.

Market Impact and Future Projections

Expanding Accessibility, Ensuring Affordability

With the introduction of Apremilast Tablets, patients in need of Otezla’s therapeutic benefits can now access a more cost-effective alternative.

This development has the potential to significantly lower the economic burden on patients while maintaining the efficacy and safety of the treatment.

Disclaimer: The information provided in this article is for informational purposes only and does not constitute medical advice. Always consult a healthcare professional for medical guidance and treatment.

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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