Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Topic	Advisory Committee	Date	Details
GSK’s mepolizumab for add-on maintenance treatment in patients 12 years and older with severe eosinophilic asthma identified by blood eosinophils >150 cells/microliter at initiation of treatment or blood eosinophils >300 cells/microliter in the past 12 months	Pulmonary-Allergy Drugs	June 11	Meeting notice (Also see "FDA Looks Likely To Split Decision On Mepolizumab Approval" - Pink Sheet, 11 Jun, 2015.)
Drugs proposed for inclusion on the withdrawn or removed list pursuant to FD&C Act sections 503A and 503B and on the section 503A bulk drug substances list; criteria FDA proposes to use to evaluate candidates to be identified as difficult to compound pursuant to sections 503A and 503B	Pharmacy Compounding	June 17-18	Meeting notice
Results of post-marketing studies evaluating the misuse and/or abuse of Purdue Pharma’s reformulated OxyContin (oxycodone extended release) and whether the reformulation had a meaningful impact on OxyContin abuse	Drug Safety and Risk Management, and Anesthetic and Analgesic Drug Products	July 7-8	Meeting notice
Lilly’s necitumumab for use in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer	Oncologic Drugs	July 9	Meeting notice