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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 3/9/15-3/9/15

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 2/24/15-2/24/15

Meeting Details:

The committees will discuss new drug application (NDA) 203324, for riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc. The combination products are used in corneal collagen cross-linking and proposed to be indicated for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 7/26/12-7/26/12

Meeting Details:

During the morning session, the committee will discuss a supplement to biologics license application (BLA) 125156 for LUCENTIS (ranibizumab) injection by Genentech, Inc., for the treatment of diabetic macular edema (DME). Ranibizumab injection is currently approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO). During the afternoon session, the committee will discuss new biologics license application (BLA) 125422, ocriplasmin intravitreal injection (proposed tradename, Jetrea) by ThromboGenics, Inc., indicated for the treatment of symptomatic vitreomacular adhesions (sVMA) including macular hole.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 2/27/12-2/27/12

Meeting Details:

The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): 1) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and 2) appropriateness of marketing a single bottle of 3 ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection. FDA's Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEYLEA by Regeneron - Dermatologic and Ophthalmic Drugs AdComm

Meeting Date: 6/17/11-6/17/11

Meeting Details:

On June 17, 2011, the committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed trade name EYLEA, sponsored by Regeneron Pharmaceuticals, Inc., indicated for the treatment of neovascular age-related macular degeneration (wet AMD).

 

       
Location: UMUC Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCANCELLED - Dermatologic and Ophthalmic Drugs AdComm

Meeting Date: 6/28/10-6/28/10

Meeting Details:

On June 28, 2010, the committee will discuss new drug application (NDA) 22340, voclosporin 10-milligram capsules, by Lux Biosciences, Inc. The proposed indication for this new drug product is treatment of noninfectious uveitis involving the posterior or intermediate segments of the eye.

 

       
Location: Sheraton Washington Beltsville, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 6/26/09-6/26/09

Meeting Details:

On June 26, 2009, the committee will discuss two different new drug applications (NDAs), NDA 22–288, BEPREVE (bepotastine besilate) ophthalmic solution, 1.5%, ISTA Pharmaceuticals, Inc., proposed for the treatment of ocular itching associated with allergic conjunctivitis, and NDA 22–358, sodium hyaluronate ophthalmic solution, 0.18%, River Plate Biotechnology, Inc., proposed for the treatment of the signs and symptoms of dry eye disease.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 12/5/08-12/5/08

Meeting Details:

The committee will discuss new drug application (NDA) 22-308, besifloxacin ophthalmic solution, Bausch & Lomb, Inc., proposed for the treatment of bacterial conjunctivitis and NDA 22-369, bimatoprost ophthalmic solution, 0.03%, Allergan, Inc., proposed for the treatment of hypotrichosis of the eyelids.

 

       
Location: Hilton Washington DC/Rockville Rockville Pike, Rockville, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 6/17/08-6/18/08

Meeting Details:

On June 17, 2008, the committee will discuss biologic licensing application (BLA) 125261, ustekinumab, a human monoclonal antibody, Centocor, Inc., proposed for the treatment of moderate to severe psoriasis. On June 18, 2008, the committee will discuss supplemental biologic licensing application (sBLA) 10379515350, etanercept, a lyophilized powder for subcutaneous injection, Immunex Corp., proposed for the treatment of moderate to severe psoriasis in the pediatric population.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 5/29/08-5/29/08

Meeting Details:

The committee will discuss new drug application (NDA) 22-212, difluprednate ophthalmic emulsion, Sirion Therapeutics, Inc., proposed for the treatment of inflammation and pain following ocular surgery.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting on iPLEDGE

Meeting Date: 8/1/07-8/1/07

Meeting Details:

The committees will meet in joint session to be briefed on iPLEDGE, the risk management program for isotretinoin products. Presentations will provide updates on risk management activities for isotretinoin since the full implementation of iPLEDGE on March 1, 2006.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-12:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Dermatologic and Ophthalmic Drugs & OTC AdComm

Meeting Date: 3/24/05-3/24/05

Meeting Details:

The committee will discuss what should be the necessary and sufficient safety database in order to evaluate the prescription (Rx) to over-the-counter (OTC) switch of topical corticosteroids, especially the database to evaluate the potential for hypothalamic, pituitary, adrenal (HPA) and growth suppression and other systemic and local adverse events.

 

       
Location: Hilton-GB, MD Related News Links: Not Available
Time: 8:00AM-5:25PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPfizer/Eyetech - Dermatologic and Ophthalmic AdComm

Meeting Date: 8/27/04-8/27/04

Meeting Details:

The committee will discuss new drug application (NDA) 21- 756, pegaptanib sodium injection (proposed tradename, Macugen) by Eyetech Pharmaceuticals, Inc., indicated for the treatment of exudative (wet) age-related macular degeneration.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management Advisory Committee

Meeting Date: 7/12/04-7/12/04

Meeting Details:

The committee will discuss new drug application (NDA) 21–701, proposed tradename TAZORAL (oral tazarotene) 1.5 milligram (mg) and 4.5 mg capsules, Allergan, Inc., proposed for the treatment of moderate to severe psoriasis, including risk management options to prevent fetal exposure.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Drug Safety and Risk Management and the Derm./Ophthalmic Drugs AdComm

Meeting Date: 2/26/04-2/27/04

Meeting Details:

The committee will discuss the following topics: (1) The effectiveness of the isotretinoin risk management program for the prevention of fetal exposure to ACCUTANE and its generic equivalents, and (2) consider whether changes to this isotretinoin risk management program would be appropriate

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 9/25/03-9/25/03

Meeting Details:

On September 25, the committee will discuss the steady designs of trials in the treatment of myopia.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 9/9/03-9/10/03

Meeting Details:

On September 9, 2003 the committee will discuss Raptiva by Genentech Inc. to be used in the treatment of adults with moderate-to-severe plaque psoriasis. On September 10, the committee will discuss NDA 21-5276 Metvix by Photocure for the treatment of basal cell carcinoma.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 3/17/03-3/17/03

Meeting Details:

The Committee will discuss NDA 21-414 Vitrase by ISTA Pharmaceuticals for the treatment of vitreous hemorrhage.

 

       
Location: Hol - GB Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 11/4/02-11/5/02

Meeting Details:

The committee will be making recommendation for a developement of a proposed draft guidance concerning the development of products for mild to moderate acne.

 

       
Location: BHOL Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 5/23/02-5/23/02

Meeting Details:

Biogen, Inc. announced that the U.S. Food and Drug Administration (FDA) will convene a Dermatologic and Opthalmic Drugs Advisory Committee on May 23, 2002 to review the registrational filing of Biogen's drug AMEVIVE (alefacept) for the treatment of moderate to severe chronic plaque psoriasis.

 

       
Location: Holiday Inn Silver Spring MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 11/16/00-11/16/00

Meeting Details:

On November 16, 2000, the committee will discuss new drug application (NDA) 50-777, Protopic (tacrolimus ointment) Ointment, Fujisawa Healthcare, Inc., for short and long term treatment of the signs and symptoms of atopic dermatitis in adult and pediatric patients 2 years of age or older.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 9/18/00-9/19/00

Meeting Details:

On September 18 through 19, 2000, the committee will discuss: (1) NDA 18-662, Accutane (isotretinoin) Capsules, Hoffmann-LaRoche, Inc., for severe recalcitrant nodular acne; and (2) NDA 21-177, (new formulation) isotretinoin capsules, Hoffmann-LaRoche, Inc., for severe recalcitrant nodular acne.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 6/29/00-6/30/00

Meeting Details:

On June 29, 2000, during the initial open session, the committee will discuss NDA 20-010, Lotrisone Lotion (clotrimazole/betamethasone diproprionate), Schering-Plough, Inc., for the treatment of the tinea pedia, tinea cruris and tinea corporis, and NDA 20-996, Dermex II Ointment (zinc oxinate), Dermex Pharmaceuticals, LLC, for the treatment of actinic keratosis, basal cell carcinoma, and squamous cell carcinoma. On June 30, 2000, the committee will discuss NDA 21-026, (miconazole nitrate, USP 0.25%) oinment, Johnson & Johnson Consumer Companies, Inc. for the treatment of diaper dermatitis.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 11/17/99-11/17/99

Meeting Details:

The subcommittee will discuss new drug application (NDA) 21-119 Visudyne™ (verteporfin for injection, QLT Therapeutics, Inc.), for treatment of age-related macular degeneration (AMD) in patients with predominantly classic subfoveal choroidal neovascularization.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 11/4/99-11/5/99

Meeting Details:

On November 4, 1999, during the morning session, the committee will discuss new drug application (NDA) 21-022, Loprox™(ciclopirox nail lacquer),Hoechst Marion Roussel, Inc., for treatment of onychomycosis. On November 4, 1999, during the afternoon session, the committee will participate in a scientific discussion of clinical trial design questions for products intended for the treatment of hand dermatitis. On November 5, 1999, during the afternoon session, the committee will discuss NDA 20-965, Levulan® (aminolevulinic acid HCL) Kerastick™ for Topical Solution, 20%, Dusa Pharmaceuticals, Inc., for use in the treatment of multiple actinic keratoses of the face and scalp.

 

       
Location: Gaithersburg Hilton Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 7/21/99-7/21/99

Meeting Details:

The subcommittee will discuss new drug application (NDA) 21-023 (cyclosporine ophthalmic emulsion, 0.05%, Allergan, Inc.),for treatment of moderate to severe keratoconjunctivitis sicca. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Hilton Hotel Salons A and B 620 Perry Pkwy. Gai Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 3/19/98-3/20/98

Meeting Details:

On March 19, 1998, the Committee will discuss generic topical dermatologicals draft guidance. On March 20, 1998, the Committee will participate in a scientific discussion of clinical trial design questions for products intended for the treatment of psoriasis.

 

       
Location: Holiday Inn, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 11/13/97-11/14/97

Meeting Details:

On November 13, 1997, the committee will discuss new drug application (NDA) 20-788, PropeciaTM (finasteride 1 milligram tablets, Merck Research Laboratories), for treatment of androgenetic alopecia to increase hair growth and to prevent further hair loss. On November 14, 1997, the committee will participate in a scientific discussion of clinical trial design questions for products intended for the treatment of burn wounds. This is one segment of an overall effort by the agency to develop a guidance document on wound healing products.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 9/4/97-9/5/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the new drug application (NDA) 20-785, SynovirTM (thalidomide capsules, Celgene Corp.), for treatment of erythema nodosum leprosum.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint meeting of the Nonprescription and the Dermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 7/16/97-7/16/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the over-the-counter status of new drug application (NDA) 20-834, Rogaine (minoxidil 5% topical solution), The Pharmacia & Upjohn Co. for use as a hair growth stimulant by men with androgenetic alopecia.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 7/14/97-7/15/97

Meeting Details:

On July 14, 1997, the committee will discuss biologic licensing application (BLA) 96-1408, Regranex (becaplermin [PDGF-BB], Chiron Corp., in a carboxymethyl cellulose gel), OMJ Pharmaceuticals, Inc., for treatment of chronic diabetic foot ulcers. On July 15, 1997, the committee will participate in a general scientific discussion regarding the development of a possible future guidance document for chronic cutaneous ulcers. This is one segment of an overall effort by the agency to provide guidance on wound healing products, including a future discussion of products for treatment of burns. The agency encourages investigators, academicians, members of the pharmaceutical industry, consumer groups, and others with information relevant to the topics to respond to the contact person.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 4/17/97-4/17/97

Meeting Details:

On April 17, 1997, the committee will hear presentations and discuss the teratogenicity and labeling issues regarding approved NDA 19-821 for Soriatane (acitretin capsules, Hoffman-LaRoche, Inc.) for use in treating severe psoriasis.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic & Ophthalmic Drugs

Meeting Date: 11/7/96-11/8/96

Meeting Details:

On November 7, 1996, the committee will hear presentations and discuss the potential for neurotoxicity of thalidomide raised by the investigational use and possible eventual approval of thalidomide for dermatologic and other indications. On November 8, 1996, the committee will hear presentations and discuss the teratogenicity of thalidomide and issues of pregnancy prevention raised by the investigational use and possible eventual approval of thalidomide for dermatologic and other indications.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Dermatologic & Ophthalmic Drugs

Meeting Date: 11/17/95-11/17/95

Meeting Details:

The committees will discuss data relevant to NDA 19-501 to switch Rogaine (minoxidil 2% topical solution, The Upjohn Co.), for use as a hair regrowth treatment for persons with androgenetic alopecia, from prescription to over-the- counter marketing status.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic Drugs

Meeting Date: 9/22/94-9/23/94

Meeting Details:

The committee will discuss onychomycosis and determination of endpoints for clinical trials investigating treatment of onychomycosis. Closed committee deliberations. On September 22, 1994, the committee will discuss trade secret and/or confidential commercial information relevant to pending investigational new drug applications.

 

       
Location: September 22 and 23, 1994, 8:30 a.m., Parklawn Bldg., conference rms. D and E, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Generic & Dermatologic Drugs

Meeting Date: 9/12/94-9/13/94

Meeting Details:

In April 1992, the Generic Drugs Advisory Committee met to consider methods for documenting the bioequivalence of topical corticosteroids. Subsequently, on July 1, 1992, the Office of Generic Drugs issued a guidance document entitled ``Interim Guidance for Topical Corticosteroids: In Vivo Bioequivalence and In Vitro Release Methods.'' The purpose of the September 1994 meeting is to reexamine the 1992 interim guidance in light of new experimental data and methods of analysis. On September 12, 1994, the committee will discuss the pharmacodynamic (i.e., vasoconstrictor) measurement of bioequivalence. On September 13, 1994, this topic will be further discussed along with other issues related to the documentation of equivalence according to the interim guidance. Discussion will be limited to dermatologic products and will not include ophthalmic or inhaled corticosteroid products. Also, on September 13, 1994, there will be a review of the current status of topics discussed at previous Generic Drugs advisory committee meetings

 

       
Location: September 12 and 13, 1994, 8:30 a.m., Parklawn Bldg., conference rms. G, H, I, and J, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsRisk Communications

Meeting Date: 6/8/15-6/9/15

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Meeting Details:

On June 8 and 9, 2015, the Committee will discuss approaches to communicating information about fetal effects in product labeling for methadone or buprenorphine maintenance therapy for opioid addiction, and about the maternal benefits and risks of treatment, to best enable patients and health care providers to make informed decisions about the use of these drugs during pregnancy.06

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsSanofi Aventis PRALUENT - Endocrinologic & Metabolic Drugs AdComm

Meeting Date: 6/9/15-6/9/15

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Meeting Details:

The committee will discuss the safety and efficacy of biologics license application 125559, proposed trade name PRALUENT (established name: Alirocumab) for injection, submitted by Sanofi Aventis, U.S., as an adjunct to diet, for long-term treatment of adult patients with primary hypercholesterolemia (non-familial and heterozygous familial) or mixed dyslipidemia including patients with type 2 diabetes mellitus, to reduce low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, tryglyceride, and lipoprotein A, and to increase high-density lipoprotein cholesterol and apolipoprotein A-1 either in combination with a statin or as monotherapy including in patients who cannot tolerate statins.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAmgen REPATHA - Endocrinologic & Metabolic Drugs AdComm

Meeting Date: 6/10/15-6/10/15

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Meeting Details:

The committee will discuss the safety and efficacy of biologics license application (BLA) 125522, proposed trade name REPATHA (established name: Evolocumab) for injection, submitted by Amgen Inc., as adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (non-HDL-C), TC/HDL-C, ApoB/ApoA1, very low-density lipoprotein cholesterol, triglyceride, and lipoprotein A, and to increase HDL-C and ApoA1, in adults with hyperlipidemia or mixed dyslipidemia, either in combination with a statin or statin with other lipid-lowering therapies (e.g., ezetimibe), or alone, or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or alone or in combination with other lipidlowering therapies in patients for whom a statin is not considered clinically appropriate. In addition, the committee will discuss the safety and efficacy of evolocumab to reduce LDL-C, TC, ApoB, and non-HDL-C, in combination with other lipid-lowering therapies (e.g. statins, LDL apheresis) in patients at least 12 years of age with homozygous familial hypercholesterolemia.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Adcomm

Meeting Date: 6/11/15-6/11/15

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Meeting Details:

The committee will discuss biologics license application (BLA) 125526, for mepolizumab for injection, submitted by GlaxoSmithKline for the proposed indication of add-on maintenance treatment in patients 12 years and older with severe eosinophilic asthma identified by blood eosinophils greater than or equal to 150 cells/microliter at initiation of treatment or blood eosinophils greater than or equal to 300 cells/microliter in the past 12 months

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Adcomm

Meeting Date: 5/12/15-5/12/15

Meeting Details:

The committee will discuss new drug application (NDA) 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, proposed for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 4/30/15-5/1/15

Meeting Details:

On April 30, 2015, the committee will discuss and make recommendations regarding the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Insert),” Product Code EWD, as unclassified under the 510(k) premarket notification authority. Circumaural Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Circumaural),” Product Code EWE, as unclassified under the 510(k) premarket notification authority. Middle Ear Inflation Devices are currently regulated under the heading, “Device, Inflation, Middle Ear,” Product Code MJV, as unclassified under the 510k) premarket notification authority. Tactile Hearing Aid Devices are currently regulated under the heading, “Hearing Aid, Tactile,” Product Code LRA, as unclassified under the 510(k) premarket notification authority. Vestibular Analysis Apparatuses are currently regulated under the heading, “Apparatus, Vestibular Analysis,” Product Code LXV, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the risks, safety and effectiveness and the regulatory classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. On May 1, 2015 the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. These issues are categorized into three broad areas for discussion: 1. Cochlear implant changes (e.g. sound processing features, patient characteristics) that may be suitable for this pre- to post-market shift in clinical data requirements. 2. Appropriate premarket clinical data requirements to support pre- to post-market shift (e.g. leveraging clinical data from adults and/or older children.) 3. Clinical study design considerations (e.g. study endpoints and test metrics, subject characteristics) for post market studies to confirm safety and effectiveness and inform future labeling.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies and ODAC

Meeting Date: 4/29/15-4/29/15

Meeting Details:

The committees will discuss talimogene laherparepvec, Amgen, Inc., biologics license application (BLA) 125518, an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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