Lupin Ltd secures USFDA approval for a new drug, shares rise

Arushi Mishra Updated - December 28, 2023 at 03:07 PM.

Lupin Limited’s shares rose 3.25 per cent after the company secured an approval from the USFDA for its Abbreviated New Drug Application, allowing the marketing of Loteprednol Etabonate Ophthalmic Suspension-0.2%. 

The newly approved generic equivalent serves as an alternative to Bausch & Lomb Inc’s reference listed drug, Alrex Ophthalmic Suspension, 0.2%. 

Lupin will manufacture the product at its facility in Pithampur, India. Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is designed for the temporary relief of signs and symptoms associated with seasonal allergic conjunctivitis. The reference product, RLD Alrex, achieved an estimated annual sales figure of $29.1 million in the U.S. as of October 2023 (IQVIA MAT).

The shares rose 3.25 per cent to ₹1,330.90 at 2.48 pm on the BSE.

Published on December 28, 2023 09:37

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