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.
SOURCE: Businesswire