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
Regulatory
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