According to MAP Pharmaceuticals, it has completed a year-long open label safety trial of its Levadex inhaled dihydroergotamine, the final step in its development program for the product. More than 250 patients completed the 12-month study. The company plans to submit an NDA for Levadex in the first half of 2011. Read the company's press release. … [Read more...] about MAP completes final Levadex trial
Regulatory
Court rules FDA has no authority to regulate e-cigarettes as drug/device combinations
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
Zenhale application withdrawn
According to the European Medicines Agency, Schering-Plough Europe (Merck) has withdrawn its marketing authorization application for its Zenhale mometesone furoate/formoterol fumarate MDI.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 about Zenhale application withdrawn
ISTA announces plans to file IND for bepotastine nasal spray
According to ISTA Pharmaceuticals, the company will file an Investigational New Drug (IND) application for its bepotastine nasal spray for allergic rhinitis by the end of this year. ISTA, which already markets a bepotastine opthalmic solution, is looking to expand its prescription eye care business into the nasal allergy arena. Read the company's press … [Read more...] about ISTA announces plans to file IND for bepotastine nasal spray
AstraZeneca gets positive opinion for Fluenz
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 (LAIV) product marketed in the US by MedImmune under the name FluMist. Read the company's press release. … [Read more...] about AstraZeneca gets positive opinion for Fluenz
Alexza receives complete response letter for Staccato loxapine
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. The FDA cited concerns about safety based on reductions in FEV 1 seen during Phase I studies and about stability studies … [Read more...] about Alexza receives complete response letter for Staccato loxapine
US FDA approves Aridol
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 in 19 countries. Read the company's press release … [Read more...] about US FDA approves Aridol
ISTA plans to file IND for nasal spray by end of year
US eye care company ISTA Pharmaceuticals announced plans to file an investigational new drug (IND) application with the FDA for its bepotastine besilate nasal spray for the treatment of seasonal allergic rhinitis by the end of 2010. The company also released results from a Phase I/II study of the nasal spray showing that the drug was well tolerated and said that … [Read more...] about ISTA plans to file IND for nasal spray by end of year
EU approval recommendation for TOBI Podhaler
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 product for EU approval in December 2009. Read the company's press release. … [Read more...] about EU approval recommendation for TOBI Podhaler
Inavir DPI for influenza gets Japanese approval
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...] about Inavir DPI for influenza gets Japanese approval