Regulatory

In a November 5, 2013 interview on CNBC, Acorda CEO Ron Cohen announced that the company has filed a regulatory application to the FDA for its diazepam nasal spray for the treatment of epilepsy. Acorda has announced previously that it planned to submit a 505(b)(2) application for the product. Cohen said that if the drug is approved, the drug could be marketed as … [Read more...] about Acorda submits regulatory application for diazepam nasal spray

The US FDA has issued a warning letter to Sunovion regarding claims made in four patient brochures aimed respectively at COPD patients currently using MDIs, DPIs, nebulized short acting beta agonists, or any medication giving insufficient control. According to the FDA, the brochures overstate the efficacy of Sunovion's Brovana arformoterol tartrate inhalation solution … [Read more...] about Sunovion gets FDA warning letter for Brovana claims

Health Canada has approved Almirall's Tudorza Genuair aclidinium bromide DPI for the treatment of COPD, Almirall Canada has announced. Forest Laboratories is partnered with Almirall on commercialization of the product in Canada and in the US. The inhaler was approved in the US, where it is called Tudorza Pressair, and in Europe, where it is called Eklira Genuair or … [Read more...] about Tudorza Genuair approved in Canada

MannKind, which resubmitted its NDA for Afrezza inhaled insulin earlier this month, has announced that, "The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014." The FDA goal is to "Review and act on 90 percent of Class 2 resubmitted original … [Read more...] about MannKind gets PDUFA date for Afrezza

According to GlaxoSmithKline, the company has submited a new drug application (NDA) to the US FDA for a once-daily fluticasone furoate (FF) dry powder inhaler for the treatment of asthma. The NDA is for 100mcg and 200mcg doses of FF delivered by the Ellipta DPI. The FDA approved GSK and Theravance's Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment … [Read more...] about GSK submits NDA for fluticasone furoate DPI

Boehringer Ingelheim has announced the approval of Striverdi Respimat olodaterol SMI for the treatment of COPD in the United Kingdom, Denmark and Iceland, noting that additional approvals in EU countries "will follow in due course." Boehringer Ingelheim Corporate Senior VP Medicine Klaus Dugi commented, "The improvements in lung function and quality of life seen … [Read more...] about Striverdi Respimat approved in the EU

Discovery Laboratories has submitted an investigational new drug (IND) application for its Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants, the company has announced. Assuming the FDA review proceeds without objection, the company says, enrollment in a planned Phase 2 study could be initiated in the 4th … [Read more...] about Discovery Labs submits IND for Aerosurf

According to MannKind Corporation, the company resubmitted its new drug application for Afrezza insulin inhalation powder for the treatment of type 1 and type 2 diabetes to the FDA on October 13, 2013. The resubmitted application includes all data from the product's clinical development program, the company said. Earlier this year, MannKind announced positive results … [Read more...] about MannKind resubmits Afrezza NDA

Teva has announced that the US FDA has approved its tobramycin inhalation solution, a generic equivalent to Novartis's TOBI inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients. According to Teva, the company will launch the product in November 2013 in accordance with an agreement with Novartis. Teva UK's marketing … [Read more...] about Teva’s generic tobramycin inhalation solution approved by FDA