Regulatory

Aradigm Corporation said that the FDA’s Antimicrobial Drugs Advisory Committee (ADAC) has voted against approval of the company’s NDA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in non-cystic… Read more . . .

A citizen petition filed by Mylan on December 5, 2017 asks the FDA not to approve any ANDA for a generic version of Advair Diskus that relies on data from multiple-batch PK bioequivalence studies “unless,… Read more . . .

The FDA said in a Drug Safety Communication that it has approved the removal of Boxed Warnings about asthma-related deaths from ICS/LABA combination inhalers. The inhalers affected by the change are Advair Diskus, Advair HFA,… Read more . . .

Medical Developments International (MVP) has announced that the Decentralized Procedure for its Penthrox methoxyflurane inhaler marketing application has been completed, and the inhaler has been approved in an additional 22 countries. Penthrox has been available… Read more . . .

Acorda Therapeutics said that it has resubmitted an NDA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson’s disease patients. The company originally submitted the 505(b)(2) application in June 2017, and… Read more . . .

Sunovion’s NDA for Lonhala Magnair glycopyrrolate inhalation solution (formerly known as SUN-101/eFlow) has been approved by the FDA for the treatment of COPD, the company said. A US launch is planned in early 2018. In… Read more . . .

Glenmark Pharmaceuticals Europe said that its marketing authorization application for a generic version of Seretide Accuhaler (Advair Diskus) for the treatment of asthma and COPD has been approved through the decentralized procedure in the Nordic… Read more . . .

Aradigm has announced that the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) will meet on January 11, 2018 to review the NDA for Linhaliq inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis… Read more . . .