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).
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 product considered to be in shortage. By launching our Magnesium Sulfate Injection and providing this high-quality generic equivalent to patients in need, we directly contribute to the realization of our ambition to make affordable medicines available to all, whether that is in the EU or the U.S."
"We are very pleased to launch this important product with our partner Milla Pharmaceuticals. This product is consistently on the FDA's Shortage List and this launch will enable the product to be utilized by patients that desperately need the drug. We look forward to additional new launches with Milla Pharmaceuticals in the future," said Jeffrey Yordon, President of APD.
About Milla Pharmaceuticals Inc.
Milla Pharmaceuticals Inc., a wholly-owned subsidiary of the Alter Pharma Group, is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the U.S. market focused on niche injectable and solution products for hospitals and clinics.
More info: About - Milla Pharmaceuticals Inc.
About Athenex Pharmaceutical Division
Athenex Pharmaceuticals is an innovative global pharmaceutical company committed to researching, developing, manufacturing, and delivering the highest quality sterile injectable products. Our quest for innovation brings unique presentations to the US market, and our commitment to excellence drives us to meet the highest possible standards.
More info: About Athenex Pharma
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