The company also received additional IP protection for its investigational Furoscix ReadyFlow autoinjector. ReadyFlow remains under FDA review after the agency accepted a supplemental New Drug Application (sNDA) earlier this month.

For the on-body infusor, the FDA approved the company’s sNDA, expanding its indication to include pediatric patients weighing 43 kg or more. It previously had approval for treating edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults.

MannKind says the additional approval fulfills all post-market requirements outlined in an initial approval letter under the Pediatric Research Equity Act.