Regulatory

The US FDA has announced the approval of MannKind Corporation's Afrezza inhaled insulin for the treatment of diabetes. The PDUFA date for Afrezza had been set for July 15, 2014 after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of the product on April 2, 2014. The product will have a boxed warning about bronchospasm … [Read more...] about FDA approves MannKind’s Afrezza inhaled insulin (updated)

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended that children aged 2-8 should get a nasal spray flu vaccine if available instead of an injection. The CDC director must approve the recommendation before it becomes an official CDC policy. The FDA approved MedImmune's FluMist Quadrivalent … [Read more...] about CDC advisory committee recommends intranasal flu vaccine over injection for children

Strativa Pharmaceuticals has announced that it has received FDA approval for its disposable single-dose device version of Nascobal cyanocobalamin nasal spray for the treatment of pernicious anemia and other vitamin B12 deficiencies. The new product will be available in September 2014 and will replace the current multi-dose product. Strativa Senior VP Brand Sales … [Read more...] about FDA approval for single-dose Nascobal cyanocobalamin nasal spray

According to Smartinhaler manufacturer Nexus6, the FDA has granted 510(k) marketing clearance for a new version of the inhaler monitoring system called SmartTouch. The system includes a touch screen on the monitoring device and is available for a number of different MDIs, including Ventolin, Advair (Seretide), and Dulera. Nexus6 CEO Garth Sutherland commented, … [Read more...] about FDA clearance for new Smartinhaler system

According to Trimel Pharmaceuticals, the FDA has approved its Natesto nasal testosterone for men with low levels of endogenous testosterone. Trimel submitted an NDA for the product, then called CompleoTRT, in April 2013. Trimel President and CEO Tom Rossi said, “The FDA approval for Natesto is a major achievement for our company, as it validates our clinical … [Read more...] about FDA approves Trimel’s Natesto testosterone nasal gel

The FDA has approved Teva's QVAR beclomethasone HFA metered dose inhaler with a dose counter for the treatment of asthma, and the company plans to launch the product later in 2014, Teva said. Teva Global Respiratory Research and Development Senior VP Tushar Shah commented, “Bringing QVAR with a dose counter to market reaffirms Teva’s commitment to addressing unmet … [Read more...] about FDA approves QVAR HFA with dose counter

GlaxoSmithKline has submitted an NDA for its umeclidinium (UMEC) Ellipta DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare, the company announced. The product was approved under the name Incruse Ellipta in the US, in Canada, and in Europe in April 2014. According to GSK, "Regulatory filings in other countries will take place … [Read more...] about GSK files application for UMEC monotherapy in Japan

Aradigm has announced that the FDA has designated its Pulmaquin inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis patients as a Qualified Infectious Disease Product (QIDP). QIDP status makes the product eligible for the FDA's Fast Track expedited review program. Aradigm CEO Igor Gonda said, "We are very … [Read more...] about Aradigm’s Pulmaquin gets QIDP status