Regulatory

MannKind, which resubmitted its NDA for Afrezza inhaled insulin earlier this month, has announced that, “The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in… Read more . . .

According to GlaxoSmithKline, the company has submited a new drug application (NDA) to the US FDA for a once-daily fluticasone furoate (FF) dry powder inhaler for the treatment of asthma. The NDA is for 100mcg… Read more . . .

Boehringer Ingelheim has announced the approval of Striverdi Respimat olodaterol SMI for the treatment of COPD in the United Kingdom, Denmark and Iceland, noting that additional approvals in EU countries “will follow in due course.”… Read more . . .

Discovery Laboratories has submitted an investigational new drug (IND) application for its Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants, the company has announced. Assuming the FDA review… Read more . . .

According to MannKind Corporation, the company resubmitted its new drug application for Afrezza insulin inhalation powder for the treatment of type 1 and type 2 diabetes to the FDA on October 13, 2013. The resubmitted… Read more . . .

Teva has announced that the US FDA has approved its tobramycin inhalation solution, a generic equivalent to Novartis’s TOBI inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients. According to Teva,… Read more . . .

The European Parliament has voted to regulate e-cigarettes under less stringent rules than drug delivery products, unless the products make medical claims. The Parliament voted to prohibit sales of e-cigarettes to any one under 18… Read more . . .

According to Eleison Pharmaceuticals, the European Commission has granted Orphan Drug Designation for the company’s inhaled lipid-complexed cisplatin (ILC) for the treatment of osteosarcoma. The sustained-release inhalation solution, which Eleison licensed from Insmed in 2011,… Read more . . .

Just days after its approval in Japan, Novartis has announced that the Ultibro Breezhaler indacaterol/glycopyrronium (QVA149) DPI has been approved in Europe for the treatment of COPD. The approval triggers $10 million milestone payments to… Read more . . .