Loteprednol etabonate, Lupin’s Conjunctivitis Eye Drop, Receives FDA Approval

Loteprednol etabonate

Lupin Ltd, a leading pharmaceutical company, has received 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 medication serves as a generic equivalent to Bausch & Lomb Inc’s reference listed drug (RLD) Alrex┬« Ophthalmic Suspension, 0.2%. Loteprednol etabonate ophthalmic suspension, 0.2%, is designed for the temporary relief of signs and symptoms associated with seasonal allergic conjunctivitis, providing a crucial solution for individuals dealing with allergic reactions affecting their eyes.

Manufactured at Lupin’s state-of-the-art facility in Pithampur, India, this approval expands access to an effective treatment for seasonal allergic conjunctivitis in the US market. The product has estimated annual sales of $29.1 million in the US, according to IQVIA MAT October 2023.

Lupin is a global pharmaceutical company with a presence in over 100 markets, including the US, India, South Africa, and regions across Asia Pacific, Latin America, Europe, and the Middle East. The company develops and commercializes a diverse range of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs).

This approval underscores Lupin’s commitment to providing affordable and accessible healthcare solutions globally. Lupin’s extensive portfolio, research capabilities, and manufacturing infrastructure contribute to its leadership in the pharmaceutical industry. The company operates 15 manufacturing sites, seven research centers, and has a dedicated team of over 20,000 professionals worldwide.

The approval of loteprednol etabonate ophthalmic suspension, 0.2%, reinforces Lupin’s position as a key player in the pharmaceutical sector and aligns with its mission to improve healthcare outcomes for patients worldwide. The company’s focus on research, innovation, and quality manufacturing contributes to its success in addressing diverse medical needs and expanding its market presence.

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