FDA Panel Recommends Approval Of Actavis’ Ceftazidime-Avibactam

Posted by on April 13, 2017

On December 5th, the Anti-Infective Drugs Advisory Committee (AIDAC) discussed new drug application (NDA) 206494 for ceftazidime-avibactam for injection, submitted by Cerexa Inc. (a subsidiary of Actavis), for the proposed indications of: Complicated Intra-abdominal Infections (cIAI), Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis and Limited Use Indication: Aerobic Gram-negative Infections with Limited Treatment Options.
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FDA panel supports approval of new “abuse-deterrent” opioid oral tablets

Posted by on August 15, 2016

On May 5, 2016, a joint panel of the Anesthetic and Analgesic Drug Products (AADPAC) and the Drug Safety and Risk Management Advisory Committees (DSaRM) supported approval of Apadaz, an opioid drug sponsored by KemPharm Inc. Apadaz is an immediate-release (IR) benzhydrocodone HCI/acetaminophen oral tablet indicated for short-term (maximum of 14 days) handling of acute pain.
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FDA Panel does not Support approval of Eteplirsen

Posted by on August 15, 2016

On April 25, 2016, the Peripheral and Central Nervous Systems Drugs Advisory Committee (PCNSDAC) voted against the market approval of the Eteplirsen drug. Developed by Sarepta Therapeutics, Eteplirsen is currently under New Drug Application (NDA) review for the treatment of Duchenne muscular dystrophy (DMD) in patients with mutations that can benefit from exon 51 skipping.
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FDA Panel Gives Acne Treatment Two Thumbs Up

Posted by on May 25, 2016

On April 15th, the FDA Nonprescription Drugs Advisory Committee (NDAC) voted unanimously in favor of the over-the-counter marketing (OTC) of adapalene gel 0.1% (Differin Gel, Galderma Laboratories) for the treatment of acne in people aged 12 years and older.
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FDA Panel Endorses Accelerated Approval of Ocaliva

Posted by on April 25, 2016

On April 7th, the FDA’s Gastrointestinal Drug Advisory Committee (GIDAC) voted unanimously (17 to 0) in favor of the accelerated approval of Ocaliva (obeticholic acid) for the treatment of primary biliary cirrhosis (PBC). PBC is a rare chronic liver condition and if left untreated can progress to hepatic fibrosis, cirrhosis, liver failure and death. If
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Nuplazid Gains Support from the FDA’s Psychopharmacologic Drugs Advisory Committee

Posted by on April 19, 2016

On March 29th, the Psychopharmacologic Drugs Advisory Committee (PDAC) voted in favor of Nuplazid (pimavanserin) for the treatment of Parkinson’s disease-related psychosis. Nuplazid (Acadia Pharmaceuticals) is a selective serotonin inverse agonist that helps to reduce hallucinations and other psychotic symptoms in some patients with Parkinson’s disease (PD), without affecting motor symptoms.
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FDA Device Panel Backs Breakthrough Bioresorbable Stent

Posted by on April 7, 2016

On March 15th and 16th, the Circulatory System Devices Panel of the Medical Devices Advisory Committee voted in support of the approval of the Absorb GT1 bioresorbable vascular scaffold (BVS) system (Abbott Vascular) to improve coronary luminal diameter in patients with ischemic heart disease due to two or more de novo coronary artery lesions (length
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Advisory Panel Votes Against the Approval of Spinal Stabilization System

Posted by on April 1, 2016

On February 19th, the FDA’s Orthopedic and Rehabilitation Devices Advisory Panel voted against the approval of the premarket application for Medtronic’s DIAM (Device for Intervertebral Assisted Motion) Spinal Stabilization implant due to a lack of clinical trial data. The minimally invasive spine implant is meant to treat patients with moderate low back pain secondary to
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FDA Denies Approval of Drisapersen for the Treatment of DMD

Posted by on February 2, 2016

The FDA has recently issued a Complete Response Letter to BioMarin Pharmaceuticals, indicating that there was insufficient evidence of effectiveness of drisapersen in the treatment of Duchenne Muscular Dystrophy (DMD) to support approval.
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FDA Panel Does Not Support Current Labeling of Fluoroquinolones

Posted by on January 25, 2016

On November 4th, the Antimicrobial Drugs Advisory Committee (ADAMC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) convened to discuss the current indications for fluoroquinolone (FQ) antibiotics.  The panels unanimously agreed that data on the risks and benefits of fluoroquinolone antibiotic drugs does not support their use in the treatment of acute bacterial
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