ANI Pharmaceuticals received 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.
"The FDA approval and launch of Methsuximide Capsules and Alendronate Sodium Oral Solution represent our ability to drive generics business growth through superior new product launch execution. Our R&D team continues to build strong momentum, and with these launches, we expect to share the top spot in CGT approvals,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!