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. The warning cites claims such as, "[GermBullet] has been laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses and … [Read more...] about FDA issues warning to company for unapproved inhaler

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 authorities recognize the MPA GMP certificate, as do agencies in some additional countries. Bend CEO Rod … [Read more...] about Bend Research gets EU GMP certificate

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. BI VP of Clinical Development and Medical Affairs, Respiratory Tunde Otulana said, “We at Boehringer Ingelheim are pleased … [Read more...] about FDA advisory committee recommends approval of Striverdi Respimat

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

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 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

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

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

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