Regulatory

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

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

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

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

According to Archimedes Pharma, the Scottish Medicines Consortium has approved the company's PecFent fentanyl pectin nasal spray for the treatment of breakthrough cancer pain for use in NHS Scotland. The product received marketing authorization in the European Union in September 2010 and is under review by the FDA for use in the US. Read the company's press release. … [Read more...] about PecFent nasal spray approved for use in Scottish national health system

According to Mannkind Corporation, the FDA has informed the company that it will need another four weeks or so before it issues a decision on the NDA for Afrezza inhaled insulin. The original action date was to be December 29, 2010. The FDA issued a complete response letter for the product in March and requested additional data. Read the company's press release. … [Read more...] about Mannkind announces delay on Afrezza decision

The US Court of Appeals for the DC Circuit has upheld a lower court finding that the FDA lacks the authority to regulate e-cigarettes. The agency had asserted that it had jurisdication and issued warning letters to five e-cigarette manufacturers in September, 2010. Read the opinion. … [Read more...] about Court rules FDA has no authority to regulate e-cigarettes as drug/device combinations

According to the European Medicines Agency, Schering-Plough Europe (Merck) has withdrawn its marketing authorization application for its Zenhale mometesone furoate/formoterol fumarate MDI. The company said that it was unable to provide data requested by the Committee for Medicinal Products for Human Use (CHMP) by the deadline. Zenhale is marketed as Dulera in the US, … [Read more...] about Zenhale application withdrawn