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Unigene says that it welcomes FDA meeting on calcitonin salmon nasal spray

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 company manufactures Fortical calcitonin nasal spray for the treatment of osteoporosis. Unigene CEO Ashleigh Palmer commented, “We are … [Read more...] about Unigene says that it welcomes FDA meeting on calcitonin salmon nasal spray

FDA committee schedules meetings to discuss inhalation NDAs

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 as live webcasts. The committee will meet on January 29, 2013 to discuss the new drug application (NDA) for Boehringer Ingelheim's olodaterol MDI … [Read more...] about FDA committee schedules meetings to discuss inhalation NDAs

GSK and Theravance submit application for UMEC/VI in Europe

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 be marketed as Anoro. The two companies submitted an NDA to the FDA for UMEC/VI in December 2012. The MAA is for 55/22mcg … [Read more...] about GSK and Theravance submit application for UMEC/VI in Europe

FDA approves Alexza’s Adasuve loxapine inhalation powder

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 and Mitigation Strategy (REMS) and is to be administered only in healthcare facilities enrolled in the Adasuve REMS program. Use … [Read more...] about FDA approves Alexza’s Adasuve loxapine inhalation powder

Acorda plans to submit 505(b)(2) NDA for diazepam nasal spray

Acorda Therapeutics says that it has completed its acquisition of Neuronex, including Neuronex's diazepam nasal spray formulation, for $6.8 million. The company also announced that it plans to submit a 505(b)(2) NDA in 2013 for the diazepam nasal spray as a treatment for seizures in epilepsy patients. In early 2012, Acorda paid $2 million to Neuronex as an option … [Read more...] about Acorda plans to submit 505(b)(2) NDA for diazepam nasal spray

“Asthma Inhalers Relief Act of 2012” fails in US House of Representatives

An effort to return remaining units of Primatene Mist epinephrine inhalers to the market failed in the US House of Representatives on December 12, 2012 by a vote of 229-182. Primatene Mist, a CFC-propelled MDI manufactured by Amphastar Pharmaceuticals, was the only over the counter asthma inhaler available in the US until it was removed from the market in accordance … [Read more...] about “Asthma Inhalers Relief Act of 2012” fails in US House of Representatives