A.forall Secures FDA Approval for Fifth Generic Drug Application on First Submission Cycle
Friday, July 26, 2024
A.forall’s U.S. subsidiary, Milla Pharmaceuticals Inc., has introduced its generic version of Precedex®—Dexmedetomidine Hydrochloride Injection in 200 mcg per 50 mL and 400 mcg per 100 mL, formulated in 0.9% sodium chloride and provided in glass bottles. This launch, made possible through a partnership with Sagent Pharmaceuticals, aims to alleviate the current supply shortages of this medication in the U.S., where it is listed on the FDA’s Drug Shortages list.
Dexmedetomidine Hydrochloride Injection is used to sedate patients who are intubated and mechanically ventilated in intensive care units. The product received a “First Cycle” Approval ANDA (Abbreviated New Drug Application), meaning it was approved on its initial review by the FDA. This achievement follows a similar success with A.forall’s Sodium Acetate Injection 2mEq/mL.
This launch marks Milla Pharmaceuticals' fifth entry into the U.S. market under an Abbreviated New Drug Application and represents the company’s second successful Paragraph IV Filing.
A.forall CEO Filip Van de Vliet emphasized the significance of this launch, stating, “While many face challenges in navigating the complexities of U.S. market entry, our team has successfully introduced another vital product to address shortages. At A.forall, our mission is to deliver high-quality, affordable medicines worldwide. This is just the start of our commitment to making essential medicines available to all.”
According to IQVIA®, Dexmedetomidine Hydrochloride had U.S. annual sales of approximately $117 million for the 12-month period ending in May 2024.
Source: businesswire.com
