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
Regulatory
Aradigm’s Pulmaquin will get EMA review under centralized procedure
Aradigm Corporation has announced that the EMA will review an Aradigm MAA for Pulmaquin inhaled liposomal ciprofloxacin under the centralized authorization procedure. According to the company, "Aradigm requested, and was granted, the centralized pathway on the basis that Pulmaquin represents a significant technical innovation for the potential treatment of non-cystic … [Read more...] about Aradigm’s Pulmaquin will get EMA review under centralized procedure
Teva Canada launches tobramycin inhalation solution
Health Canada has approved Teva Canada Limited's application for its tobramycin inhalation solution, a generic version of Novartis's TOBI inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients in Canada. The Teva tobramycin inhalation solution is now available in Canadian pharmacies, the company said. Teva Canada Limited … [Read more...] about Teva Canada launches tobramycin inhalation solution
FDA accepting comments on draft guidances for rhinitis drug development
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 The agency says that comments should be submitted by April 18, 2016 for either draft guidance in order to be considered prior to the start of work … [Read more...]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
FDA approval for Lannett’s generic version of Imitrex nasal spray
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
GDUFA date for Mylan’s generic Advair set for March 2017
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
Avanir’s Onzetra Xsail intranasal sumatriptan approved by FDA
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
Health Canada approves Natesto nasal testosterone gel
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
Mylan submits ANDA for fluticasone/salmeterol DPI
Mylan submitted an abbreviated new drug application (ANDA) to the FDA for its fluticasone propionate/salmeterol DPI, a generic version of GSK's Advair Diskus, for the treatment of asthma and COPD in December 2015, the company has confirmed. The application includes all of the doses for which Advair Diskus is marketed: 100, 250, and 500 μg fluticasone/50 μg salmeterol. … [Read more...] about Mylan submits ANDA for fluticasone/salmeterol DPI
Neurelis gets orphan drug designation for intranasal diazepam
The FDA has granted orphan drug designation to Neurelis's lead product, NRL-1 intranasal diazepam for the treatment of acute repetitive seizures in epilepsy patients, the company said. Biotie paid $1 million for an option to buy Neurelis and rights to the product in 2013 but returned the rights in July 2014. Neurelis President and CEO Craig C. Chambliss commented, … [Read more...] about Neurelis gets orphan drug designation for intranasal diazepam