We are excited to announce that we have launched the generic version of Precedex® (Dexmedetomidine Hydrochloride Injection) in partnership with Sagent Pharmaceuticals. The product is available in 200 mcg per 50 mL and 400 mcg per 100 mL glass bottles. This launch addresses the ongoing shortage of Dexmedetomidine Hydrochloride Injection in the U.S., providing a crucial option for sedation in intubated and mechanically ventilated patients in intensive care. Notably, this product received FDA First Cycle Approval, marking it as our second product to achieve this milestone. Generics play a vital role in making high-quality medicines more accessible and affordable, which is at...
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New Sodium Acetate Injection Concentration
And another achievement, enhancing medicines accessibility! A.forall, is proud to announce that its U.S. partner, Woodward Pharma Services LLC, has just commercialized its Supplemental Abbreviated New Drug Application (sANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Sodium Acetate Injection 4 mEq/mL marketed by Fresenius Kabi USA LLC. Sodium Acetate Injection, 2 mEq/mL has been commercialized since July 2021 and this newly launched 4 mEq/mL is a more concentrated version that is used to supply sodium in large intravenous (IV) fluids for patients who can’t take fluids by mouth. It’s also an ingredient in custom IV fluid...
Launch of a Generic Version of Pyridostigmine Bromide Syrup
We are proud to announce that Milla Pharmaceuticals Inc., an A.forall company, in partnership with Acella Pharmaceuticals LLC, has successfully commercialized its Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Mestinon® (Pyridostigmine Bromide Syrup) 60 mg/5mL. Pyridostigmine Bromide Syrup is indicated for the symptomatic treatment of myasthenia gravis, a neuromuscular disorder characterized by muscle weakness and rapid fatigue. A.forall CEO Filip Van de Vliet emphasized the significance of this achievement, stating, “After our rebranding into A.forall, uniting our teams and businesses under one single name that embodies our joint mission of...