Elite Pharmaceuticals files ANDA with FDA for generic dopamine agonist

ELITE PHARMACEUTICALS INC /NV/

Filed Abbreviated New Drug Application (ANDA) with FDA for an undisclosed extended-release dopamine agonist generic.
Reference product had total US sales of ~$12 million for 12 months ending August 31, 2022, per IQVIA.
Specific drug and formulation are not disclosed in the press release.
ANDA submission is a step toward marketing approval for a niche generic product.

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