Regulatory

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According to the European Medicines Agency, Schering-Plough Europe (Merck) has withdrawn its marketing authorization application for its Zenhale mometesone furoate/formoterol fumarate MDI.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

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on AstraZeneca’s MAA for its Fluenz intranasal influenza vaccine for use in children. Fluenz is the same live attenuated influenza virus… Read more . . .

Alexza Pharmaceuticals announced that it has received a complete response letter from the US FDA in regards to its application for Staccato loxapine inhalation aerosol for the treatment of agitation in schizophrenic and bi-polar patients.… Read more . . .

The FDA has approved Pharmaxis’s Aridol mannitol inhalation powder bronchial challenge test kit. According to Pharmaxis, the Aridol test takes less than half the time of a methacholine challenge test. Aridol has already been approved… Read more . . .

The European Commission’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Novartis’s TOBI Podhaler tobramycin inhalation powder for the treatment of P. aeruginosa infections in cystic fibrosis patients. Novartis submitted the… Read more . . .

Japan has approved Daiichi Sankyo’s Inavir laninamivir dry powder inhaler for the treatment of influenza. Treatment with Inavir requires only a single inhaled 40 mg dose. Read the Daiichi Sankyo  Read more . . .