Drug news
FDA approves acetylcysteine injection (APP Pharma) generic version of Acetadote
The FDA has given approval for the Abbreviated New Drug Application (ANDA) for acetylcysteine injection, from APP Pharma, indicated to prevent or lessen hepatic injury following an acetaminophen overdose. Acetylcysteine injection will be available as a 20% solution (200mg/mL) in 30mL single-dose glass vials. Acetylcysteine injection is sterile and can be used for I.V. administration. This provides the first generic alternative to Acetadote injection, from Cumberland Pharmaceuticals.
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