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.… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

According to the European Medicines Agency, Schering-Plough Europe (Merck) has withdrawn its marketing authorization application for its Zenhale mometesone furoate/formoterol fumarate MDI.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… Read more . . .