Novartis Canada has announced that it has received a Notice of Compliance from Health Canada for its TOBI Podhaler tobramycin DPI for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis patients. The product has been approved for CF patients aged six and older. The TOBI Podhaler has had orphan drug designation in the EU since 2003. According to … [Read more...] about TOBI Podhaler gets market authorization in Canada
Regulatory
Meda submits NDA for Dymista
Soon after announcing positive Phase 3 results for Dymista and saying that it would file an NDA for the product by mid-2011, Meda announced that it has gone ahead with the filing. Dymista is a fixed combination azelastine hydrochloride and fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. In the most recent announcement, Meda has … [Read more...] about Meda submits NDA for Dymista
FDA extends review period for QAB149 (indacaterol)
The FDA has informed Novartis that it needs a three-month extension for its review of data supporting the company's NDA for QAB149 (indacaterol). The new completion date for the review would be July 2011. The agency's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recently voted in favor of approving a 75 mcg dose of the drug but against approval of a 150 mcg … [Read more...] about FDA extends review period for QAB149 (indacaterol)
Insmed gets clearance for Phase 3 Arikace trial
According to Virginia biotech company Insmed, the US FDA has cleared the company's Investigational New Drug (IND) application for a Phase 3 trial of its Arikace liposomal amikacin for inhalation in nontuberculous mycobacteria lung infections. Arikace is delivered using a custom PARI eFlow nebulizer system. Renu Gupta, Insmed's Executive Vice President Development … [Read more...] about Insmed gets clearance for Phase 3 Arikace trial
FDA committee recommends approval of lower dose of indacaterol
The Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the US FDA has voted to recommend approval of the 75 mcg dose of Novartis's QAB149 indacaterol dry powder formulation for the treatment of COPD but has voted against approval of the 150 mcg dose. The vote was 13 to 4 in favor of the lower dose and 12 to 5 against recommendation of the higher dose. Trevor … [Read more...] about FDA committee recommends approval of lower dose of indacaterol
Phase 3 studies planned for nasal mist dental anesthesia
After a favorable end-of-Phase 2 meeting with the FDA, St. Renatus has announced that it plans to proceed to Phase 3 studies of its dental anesthetic, which is delivered as a nasal mist via a syringe. The nasally-administered anesthetic numbs the patient's teeth without numbing the face and lips. According to St. Renatus, the Phase 2 results showed that the nasal … [Read more...] about Phase 3 studies planned for nasal mist dental anesthesia
FDA briefing documents for PADAC meeting question indacaterol dosage
Briefing materials prepared by the FDA for the Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting scheduled for March 8, 2011 ask committee members to consider the safety of the higher dose of Novartis's indacaterol inhalation powder. The FDA had already issued a complete response letter in October 2009, in which it asked Novartis to consider lower doses. The … [Read more...] about FDA briefing documents for PADAC meeting question indacaterol dosage
Bronchitol approved for treatment of CF in Australia
Pharmaxis has received TGA approval to market its Bronchitol inhaled dry powder mannitol in Australia for the treatment of cystic fibrosis. The approval is for patients over 6 years old. Bronchitol received orphan drug designation in Australia in 2009 and has received that designation from the US FDA and the EMA as well. Read the company's press release. … [Read more...] about Bronchitol approved for treatment of CF in Australia
EC approves Fluenz intranasal flu vaccine for use in children
AstraZeneca has announced that it has received marketing authorization from the European Commission for its Fluenz nasal spray vaccine for the prevention of seasonal flu in children under 18 years old down to 24 months old. Fluenz is marketed in the US as FluMist by MedImmune. Read the company's press release. … [Read more...] about EC approves Fluenz intranasal flu vaccine for use in children
Another CRL for Afrezza
MannKind Corporation has again received a complete response letter from the FDA in regards to its application for Afrezza inhaled insulin. A previous CRL was issued in March 2010, and the company resubmitted the NDA in July of that year. The FDA is now asking for additional clinical trials using the next-generation delivery device for the product and for additional … [Read more...] about Another CRL for Afrezza