Regulatory

The European Commission (EC) has approved MedImmune's Fluenz Tetra intranasal four-strain live attenuated influenza vaccine for the prevention of flu in children aged 24 months to 18 years, parent company AstraZeneca has announced. Fluenz Tetra includes two strains of influenza A and two strains of influenza B; previous vaccines have contained only one strain of … [Read more...] about Fluenz Tetra approved in Europe for the prevention of flu in children

Taiwan's FDA has canceled marketing authorizations for calcitonin nasal sprays effective December 1 2013, and the products must be recalled within two months. According to the China Post, calcitonin nasal spray was first licensed in Taiwan in 1990. The Taiwan FDA is the latest regulatory agency to act on concerns about cancer risks posed by calcitonin nasal … [Read more...] about Taiwan FDA withdraws marketing authorization for calcitonin nasal spray

GSK and Theravance have announced that the European Commission has approved Relvar Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of asthma for patients whose disease is not adequately controlled by ICS plus an as-needed SABA and for COPD where patients do not have adequate control with regular bronchodilator use. Relvar has been approved in … [Read more...] about Relvar Ellipta approved in EU

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