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 fibrosis bronchiectasis (NCFBE) patients. The company submitted the NDA in July 2017, and the FDA granted the … [Read more...] about FDA advisory committee votes against approval of Linhaliq

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, after conducting an appropriately rigorous review under the established standards for establishing BE, generally, and for this product specifically, FDA concludes … [Read more...] about Mylan citizen petition challenges the use of multiple-batch PK BE studies to support ANDAs for generic versions of Advair

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, Breo Ellipta, AirDuo Respiclick, Dulera, and Symbicort. According to the agency, data from recent post-market requirement trials that … [Read more...] about FDA okays removal of Boxed Warning from labels for ICS/LABA inhalers

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 in the UK and Ireland, where it is marketed by Galen, and in Belgium and France, where it is marketed by … [Read more...] about Penthrox methoxyflurane inhaler approved in an additional 22 European countries

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 the FDA issued a refuse to file letter in response in August 2017. According to Acorda, the resubmitted application addresses two issues … [Read more...] about Acorda resubmits NDA for Inbrija L-Dopa DPI

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 April 2016, Sunovion announced that the Phase 3 GOLDEN-3 and GOLDEN-4 studies had met their primary endpoints. The company's initial NDA for the … [Read more...] about Lonhala Magnair glycopyrrolate inhalation solution (formerly SUN-101/eFlow) approved by the FDA

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 region, making the fluticasone/salmeterol DPI the company's first inhaled product approved by European authorities. In … [Read more...] about Glenmark’s generic fluticasone/salmeterol DPI approved in Nordic countries

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 bronchiectasis (NCFBE) patients. Linhaliq is a mix of liposome-encapsulated and unencapsulated ciprofloxacin. The company submitted … [Read more...] about FDA advisory committee schedules review of Linhaliq NDA