Elite Pharmaceuticals files ANDA for generic opiate analgesic with $720M market

ELITE PHARMACEUTICALS INC /NV/

Filed ANDA with FDA on August 17, 2023 for a generic opiate analgesic product.
FDA accepted the ANDA for review on September 19, 2023.
IQVIA reported $720 million in annual brand and generic sales for this product (12 months ending June 2023).
The specific drug product remains undisclosed.

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