USFDA approval granted for Loteprednol Etabonate Ophthalmic Suspension

This USFDA approval marks a significant stride in Lupin's commitment to providing effective solutions for prevalent ocular conditions.

The Health Master

December 28, 2023

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Last Updated on October 6, 2024 by The Health Master

USFDA approval

In a groundbreaking development, Lupin Limited, a global pharmaceutical major headquartered in Mumbai, India, has received the coveted USFDA approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for loteprednol etabonate ophthalmic suspension, 0.2%.

This USFDA approval allows Lupin to market a generic equivalent to the reference listed drug (RLD) Alrex ophthalmic suspension, 0.2%, manufactured by Bausch & Lomb Inc.

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Loteprednol Etabonate: A Glimpse into Relief

Loteprednol etabonate ophthalmic suspension, 0.2%, stands out as a pharmaceutical gem designed for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

This USFDA approval marks a significant stride in Lupin’s commitment to providing effective solutions for prevalent ocular conditions.

Navigating the USFDA Approval Maze

The intricate USFDA approval process, particularly the ANDA route, is a testament to Lupin’s dedication to compliance and excellence.

Successfully navigating this regulatory maze reflects Lupin’s meticulous approach in bringing high-quality generic drugs to the market.

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Market Dynamics: A Closer Look

With an estimated annual sales figure of USD 29.1 million in the US as of October 2023, Loteprednol etabonate holds immense market potential.

Lupin’s strategic entry into this segment promises to reshape the competitive landscape, potentially capturing a significant market share.

Pithampur Facility: The Manufacturing Hub

Lupin’s Pithampur facility in India serves as the manufacturing hub for Loteprednol etabonate ophthalmic suspension, 0.2%.

This strategic location underscores Lupin’s commitment to maintaining high production standards and cost-effectiveness.

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.

FAQs

Is Loteprednol etabonate available only in the US? No, Lupin’s global presence ensures that Loteprednol etabonate is available in multiple markets.
How does the USFDA approval impact Lupin’s market position? The USFDA approval enhances Lupin’s market position, potentially leading to increased market share and revenue.
Are there potential side effects of Loteprednol etabonate? While generally well-tolerated, it’s essential to consult a healthcare professional for information on potential side effects.
What distinguishes Lupin Limited from other pharmaceutical companies? Lupin stands out for its commitment to innovation, a diverse product range, and a global footprint.
Where can I get more information about Lupin Limited’s other products? Visit Lupin Limited’s official website for comprehensive information on their product portfolio.