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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

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GlaxoSmithKline and Theravance have withdrawn the application for their fluticasone furoate/vilanterol DPI for the treatment of COPD from the Japanese New Drug Application (JNDA) for the drug, the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

Trimel’s NDA for intranasal testosterone product accepted by the FDA

Trimel Pharmaceuticals has announced the acceptance of its NDA for CompleoTRT bioadhesive intranasal gel testosterone and the PDUFA date, February 28, 2014. The company announced submission of the NDA at the end of April 2013. According to Trimel, CompleoTRT is an intranasal gel with no smell or taste, delivered using a multi-dose applicator, that will eliminate … [Read more...] about Trimel’s NDA for intranasal testosterone product accepted by the FDA

FDA approves Breo Ellipta

The FDA has approved GSK and Theravance's Breo Ellipta fluticasone furoate/vilanterol inhalation powder for the treatment of COPD). The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted to recommend approval of Breo Ellipta in April 2013. Theravance will make a $30 million milestone payment to GSK following the approval. The FDA notes that, "The drug … [Read more...] about FDA approves Breo Ellipta