The registration dossier of Montelukast Sodium OSF will be primarily based on pharmacokinetic studies, without the need for clinical efficacy trials.
The company claims that Montelukast Sodium OSF dissolves within a few seconds when placed on the tongue to offer a complete dose of medication.
MonoSol Rx president and CEO Mark Schobel said they are pleased with the positive FDA feedback on the 505(b) (2) pathway for Montelukast Sodium OSF, which has demonstrated positive results in pilot bioequivalence studies when compared to Singulair.
"The OSF formulation also delivers an easy-to-take, taste-masked option for children taking the chewable tablets," Schobel said.