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Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that its partner, Athenex Pharmaceutical Division (APD), has just started to commercialize its abbreviated new drug application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its Generic Version of Magnesium Sulfate in Water for Injection, 2 g/50 mL (40 mg/mL), 4 g/100 mL (40 mg/mL) and 4 g/50 mL (80 mg/mL), in Non-PVC, Single-Patient Use Containers (Magnesium Sulfate Injection).
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Magnesium Sulfate Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia. When used judiciously, it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant.
Magnesium Sulfate Injection is currently on the ASHP drug shortage list of essential medications. This latest launch of Magnesium Sulfate Injection will help reduce the recent supply issues for the product experienced in the U.S.
This achievement marks the second ANDA commercialization for Milla Pharmaceuticals Inc. and the third for an Alter Pharma Group product in the U.S. market.
“It’s very exciting to see another of our products hit the U.S. market, and less than 2 years after our launch of Sodium Acetate Injection, and less than three years after the launch of our generic injectable Acetaminophen (Paracetamol IV),” said Erik Lazarich, President of the U.S. Operations of the Alter Pharma Group and Director of Milla Pharmaceuticals Inc. “Moreover, this is another…
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