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Recall Issued for Dextrose Injection
Voluntary recall for1 lot of 5% dextrose injection USP 100/150 mL container due to potential leakage and microbial growth.
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Dextrose Injection Recalled for Potential Leakage and Microbial Growth
B. Braun Medical Inc has initiated a voluntary recall of 1 lot of 5% dextrose injection USP 100/150 mL container due to potential leakage and microbial growth.
Carcinoid Syndrome Treatment Application Submitted to FDA
Lexicon Pharmaceuticals Inc has submitted a new drug application for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome.
FDA Approves Hepatic Veno-Occlusive Disease Treatment
Defibrotide sodium (Defitelio) is the first FDA-approved treatment for veno-occlusive disease.
Hepatic Veno-Occlusive Disease Treatment Approved
The FDA approved defibrotide sodium (Defitelio) for the treatment of hepatic veno-occlusive disease in adults and children who have additional kidney or lung abnormalities following hematopoietic stem cell transplantation.
Reliable Drug Pharmacy Issues Recall of Compounded Products
It turns out Reliable Drug Pharmacy's products may not be so reliable after all.
Generic Severe Chronic Pain Treatment Launched
Generic tramadol hydrochloride extended-release tablets treat moderate to moderately severe chronic pain.
FDA Approves Selective Estrogen Receptor Modulator
Evista is typically given to women after menopause to treat and prevent osteoporosis and reduce the risk of invasive breast cancer.
Glenmark's Raloxifene Hydrochloride Gets FDA Nod
The FDA has approved Glenmark Pharmaceuticals Inc's abbreviated new drug application for raloxifene hydrochloride tablets USP, 60 mg, which is the therapeutic equivalent to Eli Lilly and Company's Evista.
FDA Draft Guidance Supports Generic Abuse-Deterrent Opioids
FDA seeks to ensure that generic drugs are no less abuse-deterrent than the brand-name versions on the market.
Generic Version of Ultram Launched
Mylan is launching tramadol hydrochloride extended-release tablets a generic version of Valeant's Ultram extended-release tablets.
FDA's Draft Guidance Promotes Generic Abuse-Deterrent Opioids
The FDA has issued a draft guidance that encourages the industry's production of generic versions of opioids with abuse-deterrent formulations, while making sure they are as safe as their brand-name counterparts.
Comment Period on Return of Genetic Testing Results to Close Soon
The FDA's open comment period on the return of genetic testing results will be closing March 31, 2016.
Sodium Bicarbonate Injection Recalled
Hospira Inc, a Pfizer company, is voluntarily recalling 1 lot of 8.4% sodium bicarbonate injection due to the potential presence of particulate matter.
New Treatment for Plaque Psoriasis Approved
The FDA has approved Eli Lilly and Company's ixekizumab (Taltz) as a treatment for moderate to severe plaque psoriasis.
FDA Proposes Ban on Powdered Gloves
The FDA is proposing a ban on powdered gloves in most medical situations.
New Drug Application Submitted for Cardiovascular Disease Drug
Yosprala is a secondary prevention for cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
New Drug Application for Yosprala Resubmitted
Aralez Pharmaceuticals Inc resubmitted its new drug application to the FDA for its investigational candidate PA32540/PA8140 as secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
Xalkori Receives Approval for Expanded Use
The FDA has expanded the use of crizotinib, making it the first and only FDA-approved treatment for individuals with advanced non-small cell lung cancer whose tumors have an ROS-1 gene alteration.
FDA Approves 2 New Indications for Multiple Myeloma Drug
Evomela is the first drug approved for a high-dose conditioning indication of multiple myeloma.
Multiple Myeloma Drug Approved for 2 New Indications
Evomela is the first product to be FDA-approved for a high-dose conditioning indication for multiple myeloma.
Evomela Approved for 2 New Indications
The FDA has approved Spectrum Pharmaceuticals' melphalan for 2 new indications for patients with multiple myeloma.
FDA to Review Expanded Indication for Children's Plaque Psoriasis Drug
Enbrel would be the first systemic drug approved in the United States that treats chronic severe plaque psoriasis in pediatric patients.
Expanded Use of Enbrel for Children's Plaque Psoriasis Under Review
The FDA is reviewing Amgen's supplemental biologics license application for the expanded use of etanercept to treat pediatric patients with chronic severe plaque psoriasis.
Antibiotic Recalled Due to Potential Glass Particulate
After finding glass particulate in a vial, Teva Pharmaceuticals is recalling 1 lot of its amikacin sulfate injection USP, 1 gram/4 mL, vials.
FDA Approves First Generic Version of Viagra
Erectile dysfunction drug expected to become available on December 11, 2017.
First Generic Version of Viagra Approved
The FDA has approved Teva's generic version of sildenafil citrate.
FDA Rejects Prior Approval Supplement for Dry Eye Treatment
Restasis was originally approved in 2002 to treat chronic dry eye in patients.
Prior Approval Supplement for Restasis Bottle Rejected
Allergan received a complete response letter from the FDA for the manufacturer's prior approval supplement for cyclosporine ophthalmic emulsion, 0.05%, multi-dose preservative-free bottle.
New Formulation of Generic Asthma Drug Launched
Pulmicort Respules had annual sales of $217 million in the United States for 2015.