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ANI Pharmaceuticals Announces FDA Approval and Commercialization of Two ANDAs with CGT Exclusivity
BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":" BAUDETTE, Minn.--(BUSINESS WIRE)--\nANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced 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.\n\n\nANI’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.\n\n\n\"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.\n\n\nAbout ANI\n\n\nANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin® Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.\n\n\nForward-Looking Statements\n\n\nTo the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s g...