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Regulatory

Kamada submits MAA for inhaled AAT

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

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

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 The agency says that comments should be submitted by April 18, 2016 for either draft guidance in order to be considered prior to the start of work … [Read more...]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