Pulmonary-Allergy Drugs Advisory Committee Meeting

Pulmonary-Allergy Drugs Advisory Committee Meeting Committee Meeting : March 7, 2013 from 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 5, 2013 8:00 a.m. - 6:00 p.m. Agenda: On April 5, 2013, the committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make Shortwave Diathermy devices Class III, requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2012-N-0378.

Neurological Devices Panel of the Medical Devices Advisory Committee

Neurological Devices Panel of the Medical Devices Advisory Committee Committee Meeting February 22, 2013 8:00 a.m. - 6:00 p.m. Agenda: On February 22, 2013, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace RNS System sponsored by NeuroPace, Inc. The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications.

Pulmonary-Allergy Drugs Advisory Committee Meeting

Pulmonary-Allergy Drugs Advisory Committee Meeting Committee Meeting January 30, 2013 8:00 a.m. to 4:00 p.m. (Day 2 of 2) Agenda: The committee will discuss the new drug application (NDA) 202049, for mannitol inhalation powder (proposed trade name BRONCHITOL), for oral inhalation sponsored by Pharmaxis, for the proposed indication of management of cystic fibrosis (CF) in patients aged 6 years and older to improve pulmonary function.

Pulmonary-Allergy Drugs Advisory Committee Meeting

Pulmonary-Allergy Drugs Advisory Committee Meeting Committee Meeting on January 29, 2013 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: The committee will discuss the new drug application (NDA) 203108, for olodaterol (proposed trade name Striverdi Respimat) metered dose inhaler, sponsored by Boehringer Ingelheim, for the proposed indication of long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee Committee Meeting January 10, 2013 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss new drug application (NDA) 204042, canagliflozin tablets, proposed trade name INVOKANA, submitted by Janssen Research and Development, LLC. Canagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.