Milla Pharmaceuticals Inc.a subsidiary of Alter Pharma Group, announced that it submitted its ANDA application with Section IV certification on July 20, 2022 and received a Section IV acknowledgment letter and receipt from the FDA on August 31, 2022. After providing the required notice to the NDA holder, the Company reports that the NDA holder has not taken legal action against the Company within the statutory time limit. It is also worth noting that the product is currently listed with the FDA List of drug shortages.
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Milla Pharmaceuticals, a subsidiary of Alter Pharma Group, is engaged in the development, licensing and acquisition of prescription generic pharmaceuticals for the US market with a focus on niche injectables and solution products for hospitals and clinics. This Paragraph IV application is the first such application for Milla Pharmaceuticals, but the second such application for an Alter Pharma Group product.
“After receiving our 4th ANDA approvals in April 2022, including three in less than a year, this second Section IV filing represents another milestone in establishing our presence in the US market and is a clear endorsement of our development and regulatory capabilities,‘ commented Erik Lazarich, President of Milla Pharmaceuticals.
Around Milla Pharma
Milla Pharmaceuticals is engaged in the development, licensing/acquisition and commercialization of generic prescription drugs for the US market with a focus on niche injectables and solution products for hospitals and clinics.
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