Regulatory

The March 7 meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) for discussion of the Breo Ellipta inhaler, has been postponed due to weather. As of March 6, the meeting on GSK’s application for… Read more . . .

According to Marinomed, the company’s Coldamaris anti-virus nasal spray has been approved in Canada as a “natural health product.” The over-the-counter product has been registered in Europe, where it is licensed to Boehringer Ingelheim, since… Read more . . .

According to GSK and Theravance, the FDA has accepted their NDA for the Anoro Ellipta umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD, with a PDUFA date of December 18, 2013.… Read more . . .

The FDA and the US Federal Trade Commission (FTC) have issued a warning to a Florida company called Flu and Cold Defense LLC regarding its claims for an over-the-counter nasal vapor inhalation product called GermBullet.… Read more . . .

The Swedish Medical Products Agency (MPA) has granted Bend Research a certificate of compliance with European Union good manufacturing practice (GMP) regulations for the company’s manufacture and testing of clinical pharmaceutical supplies. All European health… Read more . . .

At its January 29, 2013 meeting, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of the 5 µg dose of Boehringer Ingelheim’s Striverdi Respima olodaterol soft mist inhaler for the maintenance treatment of COPD.… Read more . . .

On January 22, 2013, the FDA published its final cGMP rule for combination products in the Federal Register. According to the rule’s summary, “This rule is intended to promote the public health by clarifying which… Read more . . .