Regulatory

According to AstraZeneca, it has received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) for its Fluenz Tetra intranasal four-strain live attenuated influenza vaccine developed by its MedImmune subsidiary. Fluenz Tetra includes two strains of influenza A and two strains of influenza B. If approved, the vaccine would replace … [Read more...] about Positive opinion on Fluenz Tetra from CHMP

Sosei Group and Vectura have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Ultibro glycopyrronium/indacaterol inhalation capsules, which are delivered using the Breezhaler DPI, for treatment of COPD. Ultibro, also known as QVA149, was developed by Novartis, which filed the Japanese marketing application in November 2012. … [Read more...] about Ultibro inhalation capsules approved in Japan

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 11 to 2 in favor of approval for GSK's Anoro Ellipta umeclidinium/vilanterol dry powder inhaler for the treatment of COPD, according to GlaxoSmithKline and Theravance. The committee voted 10-3 in agreement that the safety of the UMEC/VI inhaler has been demonstrated and 13-0 on the question of … [Read more...] about FDA advisory committee recommends approval of umeclidinium/vilanterol inhaler

The FDA has issued a draft guidance on bioequivalence recommendations for generic fluticasone propionate/salmeterol xinafoate inhalers. Notice of the draft guidance appeared in the Federal Register for September 10, 2013. According to the agency, public responses to the draft guidance will be considered before the agency responds to a December 2009 citizen petition … [Read more...] about FDA issues draft guidance on BE for fluticasone propionate/salmeterol xinafoate

Forest Laboratories and Almirall have announced that a planned 4th quarter 2013 NDA submission for their aclidinium bromide/formoterol dry powder inhaler will be delayed due to the need to address FDA concerns regarding chemistry, manufacturing and control (CMC) specifications. The companies said that they "are working with the FDA regarding the CMC related comments … [Read more...] about NDA filing for aclidinium bromide/formoterol DPI delayed

Health Canada has announced that it is withdrawing marketing authorization for calcitonin nasal sprays as of October 1, 2013 due to concerns about cancer risks associated with the products. Injectable calcitonin products will continue to be available with additional warnings on the labels. The agency announced in July 2012 that it would conduct a safety review of … [Read more...] about Sales of calcitonin nasal sprays in Canada to end

According to Sanofi, the FDA's Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with two members abstaining, to recommend making Nasacort AQ triamcinolone acetonide nasal spray available without a prescription in the US. If the FDA approves the application, Sanofi's consumer healthcare division, Chattem, Inc. will market Nasacort AQ. Sanofi US Chief … [Read more...] about FDA advisory committee recommends approval of Nasacort AQ nasal spray OTC