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
Regulatory
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
GSK and Theravance submit NDA for UMEC/VI inhaler
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 Ellipta." The LAMA/LABA combination is a once-daily treatment. According to the companies, they plan regulatory filings for UMEC/VI in the European … [Read more...] about GSK and Theravance submit NDA for UMEC/VI inhaler
CHMP issues positive opinion on Adasuve inhaled loxapine
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 patients with schizophrenia or bipolar disorder. Alexza filed the MAA in October 2011. According to Alexza, CHMP … [Read more...] about CHMP issues positive opinion on Adasuve inhaled loxapine
“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
FDA issues letter to Alcon over Patanase marketing
The FDA issued a letter to Alcon dated November 13, 2012 regarding a sales aid that the agency says overstates the efficacy of Alcon's Patanase olopatadine hydrochloride nasal spray. In the four-page letter, the agency cites numerous examples of what it says are overstatements of the product's onset of action and the duration of relief and then requests that Alcon … [Read more...] about FDA issues letter to Alcon over Patanase marketing
Next Breath announces successful FDA inspection
Maryland-based CRO Next Breath, which specializes in OINDP analysis, has announced that an October 15, 2012 GMP inspection by the FDA found the company's Baltimore facility to be compliant. The inspection resulted in no Form 483 and no observations. Earlier this year, the World Health Organization (WHO) accredited Next Breath as a testing facility for nasal spray … [Read more...] about Next Breath announces successful FDA inspection
Savara’s AeroVanc gets orphan drug designation in US
According to Savara Pharmaceuticals, the company's AeroVanc inhaled vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients has been granted orphan drug status by the FDA. Aerovanc inhalation powder, which is delivered using a capsule-based DPI, has completed Phase 1 trials, and Savara says that it is … [Read more...] about Savara’s AeroVanc gets orphan drug designation in US