Posted by on October 13, 2017

On August 2nd, the U.S. Food and Drug Administration’s Arthritis Advisory Committee (AAC) discussed biologics license application (BLA) 761057, for sirukumab (proposed trade name PLIVENSIA™) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic
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FDA Votes in Favor of Additional Indication for Novo Nordisk’s VICTOZA

Posted by on October 12, 2017

On June 20th, 2017, the Endocrinological and Metabolic Drugs Advisory Committee (EMDAC) discussed the supplemental new drug application (sNDA) 022341,  for Novo Nordisk’s VICTOZA® (liraglutide injection) which outlined an additional indication for the product. The proposed additional indication for VICTOZA® was as an adjunct to standard treatment of cardiovascular (CV) risk factors to reduce the
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Posted by on October 6, 2017

On April 4th, the Nonprescription Drugs Advisory Committee (NDAC) discussed safety issues associated with over-the-counter (OTC) analgesic combination products used for indications such as upset stomach (i.e. heartburn, nausea, bloating, belching, gas, dyspepsia, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid OTC monograph. Industry representatives from the Consumer Healthcare Products Association
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FDA Panel Recommends Approval of Genentech’s rituximab/hyaluronidase Injection

Posted by on October 4, 2017

On March 29th, the Oncologic Drugs Advisory Committee (ODAC) discussed biologics license application (BLA) 761064 for rituximab/hyaluronidase injection (Rituximab SC), submitted by Genentech, Inc. (a member of the Roche Group). The proposed indications (uses) for the product include: Treatment of relapsed or refractory, follicular lymphoma as a single agent Previously untreated follicular lymphoma, in combination with
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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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