Regulatory

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 . . .

GlaxoSmithKline and Theravance say that they have submitted an NDA to the US FDA for an umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD to be marketed under the name “Anoro… Read more . . .

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding Alexza Pharmaceutical’s marketing application for Adasuve Staccato loxapine for the treatment of agitation in… Read more . . .