Regulatory

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

GlaxoSmithKline and Theravance have withdrawn the application for their fluticasone furoate/vilanterol DPI for the treatment of COPD from the Japanese New Drug Application (JNDA) for the drug, the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

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 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

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

According to GlaxoSmithKline, the company has submitted an application to the FDA for umeclidinium bromide (UMEC) administered using the Ellipta DPI for the treatment of COPD. The filing comes just days after GSK announced the submission of an MAA in Europe for UMEC monotherapy. The company says that it plans additional filings for the product this year. GSK and … [Read more...] about GSK submits NDA for UMEC monotherapy

Trimel Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA regarding its CompleoTRT bioadhesive intranasal gel testosterone for the treatment of testosterone deficiency in men. According to the company, the intranasal gel is fully absorbed within half and hour and would avoid the potential transference problems presented by topic gel products. … [Read more...] about Trimel submits NDA for intranasal testosterone to FDA

GlaxoSmithKline says that it has submitted a Marketing Authorisation Application (MAA) to the EMA for umeclidinium bromide (UMEC) monotherapy to be delivered using the Ellipta DPI for the treatment of COPD. UMEC is a long-acting muscarinic antagonist (LAMA). GSK and Theravance recently submitted an application in Japan for the Anoro Ellipta UMEC/vilanterol inhaler, … [Read more...] about GSK submits EU regulatory application for UMEC monotherapy

GlaxoSmithKline and Theravance have submitted an application for the Anoro Ellipta umeclidinium bromide /vilanterol (UMEC/VI) DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare (MHLW), the companies said. The submission in Japan is for 62.5/25mcg and 125/25mcg doses of UMEC/VI. In the US, the Anoro Ellipta has a PDUFA date of … [Read more...] about Anoro Ellipta application submitted in Japan