ANI Pharmaceuticals, Inc. (ANIP) announced Monday that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Applications (ANDAs) for Methsuximide Capsules USP, 300 mg and Alendronate Sodium Oral Solution 70 mg (base)/75 mL.
Methsuximide Capsules has been granted 180-day Competitive Generic Therapy (CGT) Exclusivity, and Alendronate Sodium Oral Solution is eligible for CGT Exclusivity upon launch.
ANI's Methsuximide Capsules are the generic version of the Reference Listed Drug (RLD) Celontin Capsules and ANI's Alendronate Sodium Oral Solution is the generic version of the RLD Fosamax Oral Solution.
The current annual U.S. market for Methsuximide Capsules and Alendronate Sodium Oral Solution is approximately $6.3 million, according to IQVIA, a leading healthcare data and analytics provider.
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