Regulatory

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 . . .

According to Meda, the EU has approved the company’s Dymista azelastine/fluticasone nasal spray for the treatment of seasonal and perennial allergic rhinitis. Meda submitted an MAA for the product in late 2011. The company announced… Read more . . .

Unigene Laboratories has issued a statement in response to an FDA announcement of an upcoming advisory committee meeting scheduled for March 5, 2013 to discuss whether the benefits of calcitonin salmon outweigh the risk. The… Read more . . .

The FDA’s Pulmonary-Allergy Drugs Advisory Committee has scheduled discussion of a number of new drug applications for inhalation products in the next few months. The meetings are open to the public and will be available… Read more . . .

GlaxoSmithKline and Theravance have submitted a marketing application to the EMA for their umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD. The product, which is delivered using the Ellipta DPI, would… Read more . . .

The FDA has approved Alexza Pharmaceutical’s Adasuve loxapine inhalation powder for the treatment of agitation in patients with schizophrenia or bipolar I disorder. The Staccato loxapine inhaler will be available only under a Risk Evaluation… Read more . . .