Therapy Areas: Central Nervous System
US FDA Approves Generic Version of Magnesium Sulfate in Water for Injection, in Non-PVC, Single-Patient Use Containers
9 November 2021 - - US-based Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, has received abbreviated new drug application approval from the US Food and Drug Administration 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), the company said.

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.

This achievement marks the second ANDA approval this year for Milla Pharmaceuticals Inc. and the Alter Pharma Group and clears the path for the group to the third launch of an Alter Pharma product in the US market.

Milla Pharmaceuticals Inc. is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the US market focused on niche injectable and solution products for hospitals and clinics.

Woodward Pharma Services is a specialty pharmaceutical company focused on acquiring, licensing, and commercializing brand and generic prescription drugs for the US Market.

The company has a diverse portfolio of products distributed across multiple channels.
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