June 2nd Antiviral Drugs AdComm - motavizumab (MedImmune) - FDAAC.com

June 2, 2010 – Antiviral Drugs Advisory Committee

BLA – motavizumab (MedImmune)

Agenda: On June 2, 2010, the committee will discuss biologics license application (BLA) 125283, motavizumab, MedImmune, LLC, proposing an indication for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

May 12th Arthritis Drugs and DSRM AdComm - NAPROXCINOD (NicOx) - FDAAC.com

May 12, 2010 – Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

NDA – naproxcinod (NicOx)

Agenda: On May 12, 2010, the committees will discuss new drug application (NDA) 22-478, naproxcinod 375 milligram capsule, sponsored by NicOx S.A., a non-steroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis.

May 27th EndoMet Drugs AdComm - EGRIFTA (Theratechnologies) - FDAAC.com

May 27, 2010 – Endocrinologic and Metabolic Drugs Advisory Committee

NDA – EGRIFTA (Theratechnologies)

Agenda: On May 27, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 22-505, EGRIFTA (tesamorelin acetate), sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease).

April 29th Anti-Infective Drugs AdComm - artesunate (WHO) - Live Webcast at FDAAC.com

April 29, 2010 – Anti-Infective Drugs Advisory Committee

NDA – artesunate rectal suppositories (WHO)

Agenda: On April 29, 2010, the committee will discuss the efficacy and safety of new drug application (NDA) 21-242, artesunate rectal suppositories, submitted by the World Health Organization, for the proposed use as a single dose for the initial treatment of patients with acute malaria who cannot take medication by mouth and for whom injectable treatment is not available.

May 6th PCNS Drugs AdComm - ACTHAR Gel (Questcor) - Live Webcast at FDAAC.com

May 6, 2010 – Peripheral and Central Nervous System Drugs Advisory Committee

sNDA – ACTHAR Gel (Questcor)

Agenda: On May 6, 2010, the committee will discuss supplemental new drug application (sNDA) 22-432, H.P. ACTHAR Gel (repository corticotropin injection), 80 USP units per milliliter, Questcor Pharmaceuticals, proposed for the treatment of infantile spasms.

April 22nd Anesthetic and Life Support Drugs & DSRM AdComm - ACUROX (Acura) - Webcast at FDAAC.com

April 22, 2010 –Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

NDA – ACUROX (Acura)

Agenda: On April 22, 2010, the committees will discuss new drug application (NDA) 22-451 ACUROX (oxycodone HCl and niacin) Tablets, Acura Pharmaceuticals, Inc., for the proposed indication of relief of moderate to severe pain where the use of an immediate-release, orally administered, opioid analgesic tablet is appropriate, and the results of studies evaluating the addition of niacin, added for the purpose of reducing the misuse of oxycodone.

April 13th & 14th Pharmaceutical Science and Clinical Pharmacology AdComm - FDAAC.com

April 13 &14, 2010 – Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Agenda: On April 13, 2010, the committee will receive presentations from the Office of Generic Drugs and discuss two bioequivalence topics relevant to generic drug approval: (1) Revising the BE approaches for critical dose drugs and (2) the use of partial area under the curve (AUC) for the evaluation of abbreviated new drug applications for products with complex pharmacokinetic profiles. Bioequivalence refers to the evaluation of equivalence in the rate and extent of drug absorption between two preparations of the same drug. Critical dose drugs are medicines that require a narrow (or ``critical'') dose range to achieve and maintain their intended effects and to reduce serious adverse drug reactions. The ``area under the curve'' is the area under a plot of drug concentration in the bloodstream versus time; it is a measure of the extent of exposure to a drug after a dose is administered.

Agenda: On April 14, 2010, the committee will: (1) Receive presentations from the Office of Generic Drugs (OGD) on a proposal for revision of the bioequivalence (BE) approaches, specifically to discuss the addition of a limitation on point estimates; (2) receive presentations on an awareness topic to highlight some issues associated with product instability (failure of a marketed product to meet stability specifications through the expiration date), and the potential research needs to address those issues; and (3) receive and discuss presentations from Office of Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive intracellular accumulation of phospholipids, a kind of fatty molecule, due to the use of certain drugs).

April 7th Pulmonary-Allergy Drugs AdComm - roflumilast/DAXAS (Forest Research) - Webcast at FDAAC.com

April 7, 2010 – Pulmonary-Allergy Drugs Advisory Committee

NDA – roflumilast/DAXAS (Forest Research)

Agenda: On April 7, 2010, the committee will discuss new drug application (NDA) 22-522, roflumilast (DAXAS), Forest Research Institute, for the maintenance treatment of chronic obstructive pulmonary disease associated with chronic bronchitis in patients at risk of exacerbations (worsening symptoms).