FDA Approves Magnesium Sulfate Injection From Milla Pharmaceuticals

The FDA has granted abbreviated new drug application (ANDA) approval to Milla Pharmaceuticals, a subsidiary of the Alter Pharma Group, for its generic version of magnesium sulfate in water for injection in nonpolyvinyl chloride, single-patient use containers.

Approved dosages include 2 g/50 mL (40 mg/mL), 4 g/100 mL (40 mg/mL), and 4 g/50 mL (80 mg/mL). Magnesium sulfate injection is included on the American Society of Health-System Pharmacists’ (ASHP) drug shortage list of essential medications, and the approval of this generic injection could help with supply issues in the United States.¹

Magnesium sulfate injection is indicated for the prevention of seizures in patients with preeclampsia, as well as seizure control in patients with eclampsia, a potentially life-threatening pregnancy complication. The drug effectively controls and prevents eclampsia convulsions without causing depression of the central nervous system for either the baby or the mother, according to Milla.¹

This is the second ANDA approval granted to Milla in 2021. In July, the FDA granted ANDA approval to the company’s generic sodium acetate injection 2 MEQ/mL, which the agency had placed on its drug shortages list. Intravenous (IV) sodium acetate is indicated as a sodium source for addition to large-volume IV fluids to correct or prevent hyponatremia in patients with restricted or no oral intake. The drug also functions as an additive for preparing specific IV fluid formulas when the needs of the patient cannot be met by standard electrolytes or nutrient solutions.²

“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 United States in such a short period of time,” Filip Van de Vliet, CEO of the Alter Pharma Group, said in a statement.

“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 European Union or the United States,” he said. “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.”¹

There are many drug shortages directly influenced by the COVID-19 pandemic. A combination of anticipatory purchasing and factory shutdowns in response to the health crisis has led to disruption of the pharmacy supply chain and subsequent shortages.³ The ASHP and FDA shortage lists each contain nearly 200 drugs.^4,5

Investigators have noted that there are multiple causes for drug shortages, which include discontinuation of drugs from the market, inadequate quantities of raw materials, and issues with legislation, manufacturing, or procurement. They suggested that, because of the pandemic’s effect on the supply chain, policymakers establish a stepwise transition process for patients to switch to generic versions of drugs that can be manufactured nationally,⁶ such as the generics produced by Milla.

References

1. Milla Pharmaceuticals Inc. announces approval of a generic version of magnesium sulfate in water for injection, in non-PVC, single-patient use containers. News release. Milla Pharmaceuticals Inc. November 9, 2021. Accessed November 11, 2021. https://www.businesswire.com/news/ home/20211109005804/en/Milla-Pharmaceuticals-Inc-Announces-Approval-of-a-Generic-Version-of-Magnesium-Sulfate-in-Water-for-Injection-in-Non-PVC-Single-Patient-Use-Containers

2. Milla Pharmaceuticals announces approval and launch of a generic version of sodium acetate injection 2MEQ/mL by Pfizer Inc. News release. Milla Pharmaceuticals Inc. August 26, 2021. Accessed November 11, 2021. https://www.businesswire.com/news/home/20210826005694/en/Milla- Pharmaceuticals-Announces-Approval-and-Launch-of-a-Generic-Version-of-Sodium-Acetate-Injection-2MEQmL-by-Pfizer-Inc

3. Bookwalter CM. Drug shortages amid the COVID-19 pandemic. U.S. Pharmacist. February 12, 2021. Accessed November 11, 2021. https://www. uspharmacist.com/article/drug-shortages-amid-the-covid19-pandemic

4. Drug shortages list. American Society of Health-System Pharmacists. Accessed November 29, 2021. https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?page=CurrentShortages&sort=1

5. FDA drug shortages. FDA. Accessed November 11, 2021. https://www. accessdata.fda.gov/scripts/drugshortages/default.cfm

6. Badreldin HA, Atallah B. Global drug shortages due to COVID-19: impact on patient care and mitigation strategies. Res Social Adm Pharm. 2021;17(1):1946-1949. doi:10.1016/j.sapharm.2020.05.017