This new product will be available in the strength of 6 gm/30 mL (200 mg/mL) single-dose vials in the US market, marking an expansion of Glenmark’s injectable portfolio.

Shares of Cumberland Pharmaceuticals (CPIX) doubled on Tuesday morning, reaching levels not seen since March 2023, following FDA approval of a new dosing regimen for its liver drug, Acetadote.

Glenmark’s acetylcysteine injection, 6 gm/30 mL (200 mg/mL) single-dose vials can be expected to have the same therapeutic effect as the listed drug product upon which the Agency relied as the basis ...

Glenmark’s Acetylcysteine Injection (DEL) is approved based on the safety and efficacy derived from the reference drug Acetadote Injection, as per U.S. FDA. The brand name of this drug ...