MINNETONKA, Minn.–(BUSINESS WIRE)–Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced it has filed its ANDA Application with Paragraph IV Certification on July 20th, 2022 and received a Paragraph IV Acknowledgement Letter and Receipt from FDA on August 31st, 2022. After providing the requisite notice to the NDA holder, the Company reports that the NDA holder has not commenced legal action against the Company within the statutory time frame. It is also worth noting the product is currently listed on FDA’s Drug Shortages List.
“After having received our 4th ANDA approval in April 2022, of which three over a period of less than one year, this second Paragraph IV Filing marks another milestone event in establishing our footprint in the U.S. market and a clear confirmation of our developmental and regulatory capabilities,” commented Milla Pharmaceuticals’ President Erik Lazarich.
This Paragraph IV Filing represents the first such filing for Milla Pharmaceuticals but the second such filing for a product of the Alter Pharma Group.
About Milla Pharmaceuticals
Milla Pharmaceuticals, a wholly-owned subsidiary of the Alter Pharma Group, is engaged in the development, licensing / acquisition and commercialization of generic prescription drugs for the U.S. market focused on niche injectable and solution products for hospitals and clinics.
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