According to Alexza Pharmaceuticals, it plans to resubmit its NDA for AZ-004 (Staccato loxapine) for the treatment of agitation in schizophrenic patients in July 2011. The company received a complete response letter (CRL) for the product from the FDA in October 2010. The FDA CRL cited safety concerns due to decreases in FEV1 after inhalation of a dose. Read the … [Read more...] about Alexza says it will resubmit AZ-004 NDA in July 2011
Regulatory
PecFent nasal spray approved for use in Scottish national health system
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
Mannkind announces delay on Afrezza decision
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
MAP completes final Levadex trial
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
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Zenhale application withdrawn
According to the European Medicines Agency, Schering-Plough Europe (Merck) has withdrawn its marketing authorization application for its Zenhale mometesone furoate/formoterol fumarate MDI.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