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
Regulatory
FDA issues draft guidance on BE for fluticasone propionate/salmeterol xinafoate
The FDA has issued a draft guidance on bioequivalence recommendations for generic fluticasone propionate/salmeterol xinafoate inhalers. Notice of the draft guidance appeared in the Federal Register for September 10, 2013. According to the agency, public responses to the draft guidance will be considered before the agency responds to a December 2009 citizen petition … [Read more...] about FDA issues draft guidance on BE for fluticasone propionate/salmeterol xinafoate
NDA filing for aclidinium bromide/formoterol DPI delayed
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
Sales of calcitonin nasal sprays in Canada to end
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
PADAC sets meeting date for discussion of Anoro Ellipta NDA
The FDA has announced that its Pulmonary-Allergy Drugs Advisory Committee (PADAC) will hold a public meeting on September 10, 2013 to discuss Glaxo's NDA for the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD. GSK submitted the NDA for the product in December 2012. The FDA will post background materials no later than two business days before … [Read more...] about PADAC sets meeting date for discussion of Anoro Ellipta NDA
FDA advisory committee recommends approval of Nasacort AQ nasal spray OTC
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
Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays
Patient advocacy organization Allergy & Asthma Network Mothers of Asthmatics (AANMA) has released data from a survey of patients using intranasal corticosteroid sprays showing that 90% of the patients surveyed "said they prefer to rely on medical professionals to diagnose and manage their conditions." According to the organization, the survey also showed that more … [Read more...] about Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays
CHMP issues positive opinion for Ultibro Breezhaler
Novartis has announced that its Ultibro Breezhaler indacaterol/glycopyrronium DPI (QVA149) has gotten a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) for the treatment of COPD. The company filed an MAA for the product in October 2012. Novartis Division Head David Epstein commented, "The CHMP's positive opinion supports a … [Read more...] about CHMP issues positive opinion for Ultibro Breezhaler
GSK and Theravance withdraw Relvar application in Japan
GlaxoSmithKline and Theravance have withdrawn the application for their fluticasone furoate/vilanterol DPI for the treatment of COPD from the Japanese New Drug Application (JNDA) for the drug, the companies say. Review of the JNDA, which was submitted in September 2012, will continue for the FF/VI combination inhaler for the treatment of asthma. If approved, the … [Read more...] about GSK and Theravance withdraw Relvar application in Japan
Breo Ellipta approved in Canada
GlaxoSmithKline has announced that the Breo Ellipta fluticasone furoate/vilanterol DPI has been approved for the treatment of COPD in Canada. GlaxoSmithKline Inc. President Paul Lirette said, "For over forty years, GlaxoSmithKline has been at the forefront of delivering medicines to patients with respiratory diseases. We are committed to responding to patients' … [Read more...] about Breo Ellipta approved in Canada