Elite Pharmaceuticals files ANDA for generic CNS stimulant; market $5.1B

ELITE PHARMACEUTICALS INC /NV/

ANDA accepted for review by FDA on Dec 21, 2023 for undisclosed generic CNS stimulant.
IQVIA reports annual brand and generic market sales of $5.1B for this product (12 months to June 2023).
Elite operates a cGMP and DEA-registered facility in Northvale, NJ for R&D and manufacturing.
No launch timeline or revenue guidance provided; approval and commercialization still pending.

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