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Meeting Date: 02/14/13

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Meeting Date: 02/14/13

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/10/15-9/10/15

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 206830, oxycodone immediate-release tablets, submitted by Purdue Pharma, with the proposed indication of the management of moderate to severe pain where the use of an opioid analgesic is appropriate. It has been formulated with the intent to provide abuse-deterrent properties. The pharmacokinetic data demonstrate that there is a significant food effect resulting in a significant delay in absorption and peak plasma concentration of oxycodone when taken with food. The applicant proposes to address this finding by labeling the product to be taken on an empty stomach, but patients may have difficulty complying with these instructions as the product is dosed every 4 to 6 hours as needed. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the delayed peak concentration when taken with food, and the feasibility of labeling to be taken an empty stomach as a means to mitigate the potential risks. The committees will also be asked to consider whether the potential public health benefit of the product’s abuse-deterrent properties are sufficient to outweigh the risk to patients who are prescribed the product for the management of pain.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/11/15-9/11/15

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Meeting Details:

The committees will discuss new drug application (NDA) 208090, oxycodone extended-release capsules for oral use, submitted by Collegium Pharmaceuticals, proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. This product has been formulated with the intent to provide abuse-deterrent properties. Pharmacokinetic data demonstrate that, in order to deliver the intended amount of oxycodone, the drug product must be taken with food. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the extent of the food effect, and potential fluctuations in oxycodone levels that may occur if the product is not taken consistently with the same amount of food. In addition, the committees will be asked to review and discuss whether the data characterizing the abuse-deterrent properties support the likelihood that this drug product will have a meaningful effect on abuse and whether potential benefits to the public from abuse-deterrent properties outweigh potential risks to patients from the effect of food. The committees will be asked to vote on whether this product should be approved for marketing in the United States.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory

Meeting Date: 9/15/15-9/15/15

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Meeting Details:

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/16/15-9/16/15

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Meeting Details:

On Wednesday, September 16, 2015, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for DUREZOL (difluprednate ophthalmic emulsion) 0.05%, Phenylephrine Hydrochloride Ophthalmic Solution, ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension), BETHKIS (tobramycin Inhalation Solution), INTELENCE (etravirine), PREZISTA (darunavir), VIRAMUNE XR (nevirapine), EPIDUO (adapalene and benzoyl peroxide), EXJADE (deferasirox), DOTAREM (gadoterate meglumine), FYCOMPA (perampanel), RECOTHROM (thrombin, topical [recombinant]), PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). As mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for the PLEXIMMUNE, ELANA SURGICAL KIT (HUD), Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD), ENTERRA™ Therapy System, and CONTEGRA Pulmonary Valved Conduit.

 

       
Location: Double Tree by Hilton 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-6:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 9/24/15-9/24/15

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Meeting Details:

On September 24, 2015, the committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 10/23/15-10/23/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 11/3/15-11/3/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207959, enclomiphene citrate 12.5 milligram (mg) and 25 mg capsules, submitted by Repros Therapeutics, Inc., for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/milliliter (ml)), younger than 60 years of age with a Body Mass Index (BMI) over 25 kilograms (kg)/meters squared (m2).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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