Regulatory

Theravance Biopharma and Mylan have announced that the NDA for revefenacin (TD-4208) inhalation solution for the treatment of COPD the companies submitted in November 2017 has been accepted for review by the FDA, with a PDUFA target date of November 13, 2018. According to the companies, the agency has said that it is not currently planning to have an advisory … [Read more...] about FDA accepts revefenacin NDA for review

Aradigm Corporation has received a complete response letter from the FDA in response to its NDA for Linhaliq dual release inhaled ciprofloxacinfor the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. An FDA advisory committee recently voted against recommending approval of the application. According to … [Read more...] about Aradigm receives CRL for Linhaliq

According to GlaxoSmithKline and Innoviva, the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding approval of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma that is adequately controlled with an inhaled corticosteroid and a LABA. The companies said that they expect to get the final … [Read more...] about CHMP adopts positive opinion on Relvar Ellipta for additional indication

The Icelandic Medicines Agency has approved an MAA filed by Medical Developments International (MVP) to allow marketing of Penthrox inhaled methoxyflurane for the treatment of pain due to traumatic injury. The company said that Penthrox would be available for sale in Iceland immediately after the approval, which was dated January 16, 2018. In December 2017, MVP … [Read more...] about Iceland approves Penthrox inhaled methoxyflurane

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