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… Read more . . .

GlaxoSmithKline and Theravance have withdrawn the application for their fluticasone furoate/vilanterol DPI for the treatment of COPD from the Japanese New Drug Application (JNDA) for the drug, the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

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… Read more . . .

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.… Read more . . .

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.… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .