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Hope Pharmaceuticals today announced the launch of Nithiodote© (co-packaged Sodium Nitrite Injection, USP and Sodium Thiosulfate Injection, USP), a new antidote indicated for the treatment of acute cyanide poisoning that is judged to be life-threatening. Because the introduction of new antidotes for the treatment of chemical threats can enhance public safety and homeland security, the [...]
ABBOTT PARK, Ill., – Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved two new strengths for three-month administration of Lupron Depot-PED ® (leuprolide acetate for depot suspension) for the treatment of children with central precocious puberty (CPP). CPP is a condition that causes children to enter puberty too [...]
PRINCETON, N.J. & WILMINGTON, Del. – Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today reported the outcome of the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin. “Do the efficacy and safety data provide substantial evidence to support [...]
Basel, – Novartis announced today that the US Food and Drug Administration (FDA) has approved once-daily Arcapta(TM) Neohaler(TM) (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema[1]. Arcapta is not indicated for acute deteriorations of COPD or [...]
The U.S. Food and Drug Administration today approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic). Neuroendocrine tumors found in the pancreas are slow-growing and rare. It is estimated that there are [...]
PHOENIX – INSYS Therapeutics, Inc. (formerly NeoPharm, Inc.) (Other OTC:NEOL) today announced that the U.S. Food and Drug Administration (FDA) has provided an anticipated Prescription Drug User Fee Act (PDUFA) goal date of January 4, 2012 for its review of the New Drug Application (NDA) for Fentanyl SL Spray. “We look forward to working with [...]
PEAPACK, N.J. - Greenstone LLC announced today that it is voluntarily conducting a recall, to the patient level, of medicines with lot number FI0510058-A on the label. This includes Citalopram 10mg Tablets (100-count bottle) and Finasteride 5mg Tablets (90-count bottle), both distributed in the U.S. market. The recall is due to the possibility that incorrect labels [...]
PRINCETON, N.J.-Bristol-Myers Squibb Company (NYSE: BMY) today announced that a clinical trial – known as study 024 – of its investigational compound ipilimumab has met the primary endpoint of improving overall survival in previously-untreated patients with metastatic melanoma. Study 024 was designed to assess overall survival in unresectable stage III or stage IV melanoma patients [...]
INDIANAPOLIS and PHILADELPHIA, March 18, 2011 – Eli Lilly and Company (NYSE: LLY) and its wholly owned subsidiary, Avid Radiopharmaceuticals, Inc., have received a complete response letter from the U.S. Food and Drug Administration (FDA) for their New Drug Application (NDA) for Amyvid™ (florbetapir F 18 injection), a Positron Emission Tomography (PET) imaging agent under [...]
INDIANAPOLIS, March 17, 2011 – Eli Lilly and Company (NYSE: LLY) announced today that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo® [teriparatide (rDNA origin) injection] in the United States. The Triad Group is recalling the alcohol prep pads due [...]
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