A wholly subsidiary of Fresenius Kabi Pharmaceuticals, APP Pharma expects to launch extended product line of its current portfolio in next few months.
The company will market Levothyroxine Sodium for Injection in single dose 100mcg, 200mcg, and 500mcg vials.
APP Pharma president and CEO John Ducker said APP worked closely with the FDA to secure approval of Levothyroxine Sodium for Injection because of the expressed medical need for this drug.
"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," Ducker said.