Third Alter Pharma product for US market receives ANDA approval from FDA

ANDA approval of Magnesium Sulfate Injection marks the second ANDA approval this year for Milla Pharmaceuticals Inc. and the Alter Pharma Group and clears the path to the third launch of an Alter Pharma product in the US market, after the successful launch of Alter Pharma’s generic versions of Paracetamol IV in December 2020 and of Sodium Acetate Injection in July 2021

Alter Pharma is pleased to announce that its American subsidiary, Milla Pharmaceuticals, has received 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, respectively. 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 approval and near-term launch of Magnesium Sulfate Injection will help to reduce supply issues experienced in the US.

“Not only are we extremely proud that, after the launch of our generic injectable Acetaminophen (Paracetamol IV) in December 2020 and of our generic version of Sodium Acetate Injection in July 2021, we are now lining up our third launch in the US in such a short period of time”, said Filip Van de Vliet, CEO of the Alter Pharma Group, “we are also putting into action our ambition to make affordable medicines available to all and to address critical drug shortages, whether they are in the EU or the US. Magnesium Sulfate Injection is another example of a product in shortage in the US market for which we can offer a high-quality generic equivalent to the patients in need.”

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