Elite Pharmaceuticals files ANDA for generic opiate analgesic product
The FDA accepted for review Elite's undisclosed generic drug product in a class of medications called opiate analgesics.
Elite, a specialty pharmaceutical company engaged in the development, manufacture and distribution of niche generic products, announced that it filed an Abbreviated New Drug Application on Aug. 17, 2023, and was accepted for review by the Food and Drug Administration on Sept. 19, 2023 for an undisclosed generic drug product in a class of medications called opiate analgesics.
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The brand and generic market for this product for the 12 months ending June 2023 was $720 million, per IQVIA.