A.forall Announces the Launch of Their Fifth Abbreviated New Drug Application (ANDA) and Second “First Cycle” FDA Approval

MINNETONKA, Minn.--(BUSINESS WIRE)--A.forall’s U.S. subsidiary Milla Pharmaceuticals Inc. announced the launch of the group’s generic version of Precedex®, Dexmedetomidine Hydrochloride Injection 200 mcg per 50 mL and 400 mcg per 100 mL in 0.9% sodium chloride in glass bottles by its partner Sagent Pharmaceuticals.

Dexmedetomidine Hydrochloride Injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.

Dexmedetomidine Hydrochloride Injection 200 mcg per 50 mL and 400 mcg per 100 mL is currently on FDA’s Drug Shortages list. This latest launch of Dexmedetomidine Hydrochloride Injection will help reduce the recent supply issues for the product experienced in the U.S.

The product is now launched after having obtained a so-called “First Cycle” Approval ANDA (abbreviated new drug application), meaning it was approved on the first cycle of an FDA review, which was also the case for A.forall’s Sodium Acetate Injection 2mEq/mL.

Dexmedetomidine Hydrochloride Injection is the fifth A.forall Abbreviated Drug Application that Milla Pharmaceuticals introduces into the U.S. market and also marks the second successful Paragraph IV Filing.

“While many others struggle to crack the scientific and regulatory complexity of launching a product on the U.S. market, with Dexmedetomidine Hydrochloride Injection, our team managed to bring yet another product to U.S. patients of which there is a critical shortage. And that’s exactly what at A.forall we get out of bed for every morning: offer high-quality, affordable medicines to patients in need, whether in the U.S., the EU or the rest of the world. We are only at the beginning of our journey of making affordable medicines available to all”, commented A.forall CEO Filip Van de Vliet.

According to IQVIA®, U.S. annual sales for Dexmedetomidine Hydrochloride for the 12 months ended May 2024 were approximately $117 million.

Please see link for Full Prescribing Information.

About A.forall & Milla Pharmaceuticals

At A.forall, we Make Affordable Medicines Available To All: we develop value-added generic pharmaceuticals, solve product shortages and fill unmet medical needs so that patients can continue their treatment.

At the same time, we are reducing costs to the healthcare system and increasing customer convenience for a more sustainable world.

Milla Pharmaceuticals Inc., the U.S. subsidiary of A.forall, is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the U.S. market, focusing on niche injectable and solution products for hospitals and clinics.

More info: About – A.forall & About - Milla Pharmaceuticals Inc.

About SAGENT Pharmaceuticals

SAGENT Pharmaceuticals® is a leading provider of injectable pharmaceuticals. Sagent’s extensive product portfolio offers flexibility across diverse therapeutic categories and packaging configurations including vials, syringes, and premix bags, fulfilling the evolving needs of patients. Discover Injectables Excellence®: Visit www.sagentpharma.com and follow us on LinkedIn.