ANI Pharmaceuticals, Inc. and Eton Pharmaceuticals, Inc. have announced the approval and launch of the first generic version of carglumic acid tablets in the US. The companies’ application for a Carbaglu rival was granted a Competitive Generic Therapy designation by the US Food and Drug Administration, along with 180 days of related generic exclusivity.
Commenting on the development, Nikhil Lalwani, CEO of ANI said, “This approval further strengthens ANI’s focus on niche opportunities and
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