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
Regulatory
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
US survey finds support for regulation of e-cigarettes
A survey sponsored by the University of Michigan's C. S. Mott Children's Hospital found support for regulation of e-cigarettes, with 82% of the US adults polled agreeing that the FDA should regulate the products. Approximately 70% of respondents also thought that e-cigarettes should be banned in workplaces and should carry health warnings. Read the report. … [Read more...] about US survey finds support for regulation of e-cigarettes
Marketing authorization for PecFent nasal spray
According to Archimedes Pharma, the European Commission has granted marketing authorization for the company's PecFent fentanyl nasal spray for the treatment of breakthrough pain in adult cancer patients. Archimedes submitted an NDA for the product to the US FDA in 2009 and is waiting for US approval. Read the company's press release. … [Read more...] about Marketing authorization for PecFent nasal spray