FDA approves Discovery Labs Afectair

The US Food and Drug Administration (FDA) has approved Discovery Laboratories' proprietary patient interface technology, Afectair.

Afectair is a proprietary disposable ventilator circuit/patient interface connector that simplifies the delivery of aerosolized medications to critical-care patients requiring ventilatory support from either intermittent mechanical ventilation or continuous positive airway pressure.

Discovery Labs CEO and board chairman Thomas Amick said they are eager to move this proprietary technology to commercialization in the latter part of 2012.

Discovery Labs senior vice president and COO Thomas Miller said in preparation for this milestone, they identified a number of operational and commercial options intended to support the commercial introduction of Afectair.

"We are now focused on implementing a commercial plan that includes the establishment of key strategic manufacturing and distribution relationships,' Miller said.

Discovery Labs is also receiving CE mark for commercialization of the initial Afectair products in the European Union (EU) in late 2012.