Second Paragraph IV Filing for an Alter Pharma Product in US

Milla Pharmaceuticals successfully completed its first own Paragraph IV Filing with the FDA, marking the second Paragraph IV Filing of an Alter Pharma product for the US Market

The Alter Pharma Group is pleased to announce that its American subsidiary, Milla Pharmaceuticals Inc., has successfully filed its first own ANDA Application with Paragraph IV Certification on 20 July 2022, for which it received a Paragraph IV Acknowledgement Letter and Receipt from the FDA on 31 August 2022.

The product concerned is currently listed on FDA’s Drug Shortages List and therefore directly contributes to the realization of Alter Pharma’s mission to Making Affordable Medicines Available To All.

“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.

For the full press release, click here