USFDA approval granted for generic Letermovir Tablets

This approval paves the way for Lupin to enter the lucrative market for cytomegalovirus (CMV) infection prophylaxis in adult stem cell transplant recipients.

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USFDA Drug product Approval
USFDA Approval

Last Updated on June 15, 2024 by The Health Master

USFDA approval

Indian pharmaceutical giant Lupin Limited has received a significant boost with the tentative U.S. Food and Drug Administration approval (USFDA approval) of its generic letermovir tablets.

This approval paves the way for Lupin to enter the lucrative market for cytomegalovirus (CMV) infection prophylaxis in adult stem cell transplant recipients.

A Generic Equivalent of Prevymis® Tablets

Lupin’s letermovir tablets are available in two strengths: 240 mg and 480 mg.

These tablets are designed to be a generic alternative to Prevymis® tablets, a brand-name medication manufactured by Merck Sharp & Dohme LLC.

The USFDA approval signifies that Lupin’s tablets meet the USFDA’s rigorous standards for safety, efficacy, and bioequivalence to the brand-name drug.

Addressing a Critical Need in Stem Cell Transplants

Cytomegalovirus (CMV) is a major concern for patients undergoing allogeneic hematopoietic stem cell transplants.

This type of transplant involves replacing a patient’s diseased or damaged bone marrow with healthy stem cells from a donor.

However, CMV infection can be a serious complication after such transplants, potentially leading to illness and even death.

Letermovir tablets play a vital role in preventing CMV infection by suppressing the replication of the virus.

This USFDA approval offers a potentially more affordable option for healthcare providers and patients seeking effective CMV prophylaxis following stem cell transplants.

Unlocking a Multi-Million Dollar Market

According to IQVIA MAT April 2024 data, the brand-name Prevymis® tablets had an estimated annual sale of USD 314 million in the U.S. market alone.

Lupin’s generic letermovir tablets, with their anticipated lower cost, have the potential to significantly disrupt this market and make this critical medication more accessible to patients.

What’s Next for Lupin?

While the USFDA has granted tentative approval, Lupin will need to complete certain post-approval requirements before it can officially launch its generic letermovir tablets in the U.S. market.

This is a positive step forward for Lupin, and the company is well-positioned to capitalize on this opportunity and expand its reach in the U.S. pharmaceutical landscape.

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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