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Regulatory

NICE recommends TOBI Podhaler and Colobreathe for CF patients

The UK's National Institute for Health and Clinical Excellence (NICE) has issued a qualified recommendation for Forest Lab's Colobreath colistimethate sodium and Novartis's TOBI Podhaler tobramycin dry powders for inhalation as options for the treatment of P. aeruginosa lung infections in patients with cystic fibrosis. The recommendation is a final draft; the final … [Read more...] about NICE recommends TOBI Podhaler and Colobreathe for CF patients

FDA issues final cGMP rule for combination products

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 CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a … [Read more...] about FDA issues final cGMP rule for combination products

Meda’s Dymista gets European approval

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 the FDA's approval of Dymista in May 2012. The European approval was made through the decentralized procedure, and Meda says that it … [Read more...] about Meda’s Dymista gets European approval

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

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

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