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FDA Approves Milla Pharmaceuticals Magnesium Sulfate Injection

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The agency’s green light could help remove the drugs from the ASHP’s drug shortage list by reducing supply issues.

The FDA has granted Abbreviated New Drug Application (ANDA) approval to Milla Pharmaceuticals, a subsidiary of Alter Pharma Group, for its generic version of Magnesium Sulfate in Water for Injection in single-use chloride containers. of non-polyvinyl.

Approved strengths 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 on the American Society of Health-System Pharmacists’ (ASHP) Essential Drug Shortages List, and approval of this generic injection could help address supply issues in the United States. United.1

Magnesium sulfate injection is indicated for the prevention of seizures in patients with preeclampsia, as well as for the control of seizures in patients with eclampsia, a life-threatening pregnancy complication. The drug effectively controls and prevents eclampsia seizures without causing central nervous system depression in 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 list of drug shortages. Intravenous (IV) sodium acetate is indicated as a source of sodium to add to large-volume IV fluids to correct or prevent hyponatremia in patients with limited or no oral intake. The drug also functions as an additive to prepare specific IV fluid formulations when patient needs cannot be met by standard electrolytes or nutrient solutions.2

“Not only are we extremely proud that following the launch of our generic acetaminophen (paracetamol IV) injection in December 2020 and our generic sodium acetate injection version in July 2021, we will now be lining up our third US launch United in such a short time,” Filip Van de Vliet, CEO of Alter Pharma Group, said in a statement.

“We are also implementing our ambition to make affordable medicines available to everyone and to address critical medicine shortages, whether in the European Union or the United States,” he said. “Magnesium Sulfate Injection is another example of a product in short supply in the US market for which we can offer a high-quality generic equivalent to patients in need.”1

There are many drug shortages directly influenced by the COVID-19 pandemic. A combination of advance purchases and factory closures in response to the health crisis has led to disruption in the pharmacy supply chain and resulting shortages.3 The ASHP and FDA shortage lists each contain nearly 200 drugs.4.5

The investigators noted that there are multiple causes for the drug shortages, including the discontinuation of drugs from the market, insufficient quantities of raw materials and problems with legislation, manufacturing or supply. They suggested that due to the effect of the pandemic on the supply chain, policymakers establish a phased transition process for patients to transition to generic versions of drugs that can be manufactured domestically. ,6 like the generics produced by Milla.

The references

1. Milla Pharmaceuticals Inc. announces the approval of a generic version of Magnesium Sulfate in Water for Injection, in PVC-free single-use containers. Press 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-into-single-use-containers-PVC-free

2. Milla Pharmaceuticals Announces Approval and Launch of Generic Version of Sodium Acetate Injection 2MEQ/mL by Pfizer Inc. Press 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. American pharmacist. February 12, 2021. Accessed November 11, 2021. https://www. uspharmacist.com/article/drug-shortages-amid-the-covid19-pandemic

4. List of drug shortages. American Society of Healthcare 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 Admin Pharm. 2021;17(1):1946-1949. doi:10.1016/j.sapharm.2020.05.017