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WASHINGTON (dpa-AFX) – ANI Pharmaceuticals, Inc. (ANIP) announced on Thursday the launch of Prucalopride Tablets, the generic version of the reference drug (RLD) Motegrity.
The launch follows the US Food and Drug Administration’s (FDA) final approval of its Abbreviated New Drug Application (ANDA).
The FDA has granted Prucalopride tablets a Competitive Generic Therapy (CGT) designation, with 180 days of exclusivity.
Annual sales of Prucalopride tablets in the US are approximately $168.0 million, based on IQVIA data as of October 2024.
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