APP Pharmaceuticals gets FDA OK for myxedema coma treatment

SCHAUMBURG, Ill. — APP Pharmaceuticals has received regulatory approval for the treatment of a complication related to hypothyroidism.

APP said that its levothyroxine sodium for injection will be marketed in single-dose 100-mcg, 200-mcg and 500-mcg vials. The drug is designed to treat myxedema coma, a life-threatening complication of hypothyroidism.

“APP worked closely with the FDA to secure approval of levothyroxine sodium for injection because of the expressed medical need for this drug,” APP Pharmaceuticals president and CEO John Ducker said. “We will continue to collaborate with the FDA to gain approval of established and much-needed drugs that maintain the highest standards of quality, safety and efficacy.”