Regulatory

According to Boehringer Ingelheim Pharmaceuticals, the FDA has approved a supplemental NDA for the Stiolto Respimat tiotropium/olodaterol SMI for a labeling change to add quality of life data obtained from the OTEMTO 1&2 studies. Stiolto Respimat, which was initially approved for the treatment of COPD by the FDA in May 2015, is approved as Spiolto Respimat in some … [Read more...] about FDA approves sNDA for Stiolto Respimat

Kamada has submitted a Marketing Authorization Application for its inhaled alpha-1 antitrypsin (AAT) therapy for the treatment of AAT deficiency to the European Medicines Agency, and the filing EMA has validated the application, the company said. In September 2014, Kamada announced that it planned to move forward with regulatory submissions for inhaled AAT despite … [Read more...] about Kamada submits MAA for inhaled AAT

The FDA has granted Qualified Infectious Disease Product (QIDP) designation to Raptor Pharmaceutical's MP-376 inhaled levofloxacin for the treatment of chronic P. aeruginosa lung infections in patients with cystic fibrosis, non-cystic fibrosis bronchiectasis (BE), and nontuberculous mycobacteria (NTM). Raptor has previously received orphan designation from the FDA for … [Read more...] about Raptor’s inhaled levofloxacin gets QIDP status

The FDA published notices on February 16, 2016 announcing publication of draft guidances titled “Allergic Rhinitis: Developing Drug Products for Treatment” and "Nonallergic Rhinitis: Developing Drug Products for Treatment. The agency says that comments should be submitted by April 18, 2016 for either draft guidance in order to be considered prior to the start of work … [Read more...] about FDA accepting comments on draft guidances for rhinitis drug development

Lannett Company has received FDA approval for its sumatriptan nasal spray, a generic version of GSK's Imitrex nasal spray. The company cites IMS statistics showing that US sales of sumatriptan nasal spray totaled $62 million in 2015. Lannett CEO Arthur Bedrosian commented, "We believe our sumatriptan nasal spray USP, 5 mg/spray and 20 mg/spray will be a … [Read more...] about FDA approval for Lannett’s generic version of Imitrex nasal spray

The FDA has accepted Mylan's abbreviated new drug application for its generic fluticasone propionate/salmeterol DPI and has set a GDUFA goal date of March 28, 2017, the company said. Mylan filed the ANDA for the generic version of GSK's Advair Diskus in January 2016. Mylan CEO Heather Bresch commented, "The FDA's acceptance of our ANDA filing is an important … [Read more...] about GDUFA date for Mylan’s generic Advair set for March 2017

The FDA has approved Avanir Pharmaceuticals' intranasal sumatriptan for the treatment of acute migraines, the company said. The product, which Avanir licensed from OptiNose in 2013, will be marketed in the US as Onzetra Xsail. Avanir submitted an NDA for the product, then known as AVP-825, in January 2014 and received a complete response letter from the FDA in … [Read more...] about Avanir’s Onzetra Xsail intranasal sumatriptan approved by FDA

Acerus Pharmaceuticals has received approval from Health Canada to market Natesto nasal gel as a testosterone replacement therapy in adult males with hypogonadism, and the product should be available in Canada by mid-2016, the company said. Acerus President and CEO Tom Rossi said, “Natesto addresses many of the gaps with current testosterone replacement therapies. … [Read more...] about Health Canada approves Natesto nasal testosterone gel