India, July 24 -- MannKind Corp. (MNKD), a biopharmaceutical company, announced Friday that it received U.S. FDA approval for Furoscix ReadyFlow to treat edema in adults with heart failure or chronic kidney disease.
The FDA approval was supported by clinical results that showed Furoscix ReadyFlow met its primary pharmacokinetic endpoint, demonstrating intravenous-equivalent drug exposure.
The study also demonstrated comparable urine output, sodium excretion and potassium excretion at 6, 8 and 12 hours versus intravenous Furosemide. Furoscix ReadyFlow was generally well tolerated, with a safety profile consistent with oral and intravenous Furosemide.
MannKind expects to commercially launch Furoscix ReadyFlow autoinjector in the U.S. by th...