The US FDA has approved Warner Chilcott's 400mg mesalamine product as new ulcerative colitis therapy, to be marketed as Delzicol. Warner expects to commercially launch Delzicol in March 2013. Delzicol delayed-release capsules are ...
The US FDA's biomarker qualification group has extended license of the GVK Biosciences clinical biomarker database (GOBIOM). The GOBIOM database assists FDA in its biomarker qualification process by providing most recent information on ...
The US FDA has granted Soligenix fast track designation for OrbeShield for the reduction of mortality associated with gastrointestinal acute radiation syndrome (GI ARS). The oral beclomethasone 17,21-dipropionate (oral BDP) earlier ...
Tags: US FDA, Soligenix, fast track designation, OrbeShield
The US FDA has accepted Genzyme Lemtrada (alemtuzumab) biologics license application (sBLA) for review for relapsing multiple sclerosis (RMS). Genzyme also reported encouraging early US launch indicators for Aubagio (teriflunomide) such ...
Tags: FDA, biologics license application, relapsing multiple sclerosis
The US FDA has issued marketing approval for Lupin Pharmaceuticals' Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1mg / 0.02mg, the combined oral contraceptive. Levonorgestrel and Ethinyl Estradiol Tablets are the generic equivalent ...
Tags: FDA, Oral Contraceptive Medication, Lupin Pharmaceuticals
The US FDA has approved Cangene's Varizig for post-exposure prophylaxis of varicella in patients including immunocompromised children, newborns and pregnant women. The hyperimmune product that contains antibodies specific for the ...
Tags: FDA, hyperimmune product, Varicella Zoster Immune Globulin, U.S.A
Thoratec has gained an investigational device exemption(IDE)from the US Food and Drug Administration(FDA)for the initiation of a feasibility clinical study of its continuous-flow left ventricular assist device(LVAD),for the treatment of ...
US FDA has approved Watson Pharmaceuticals' abbreviated new drug application (ANDA) for Oxycodone and Acetaminophen tablets, USP 7.5 mg/500 mg and 10 mg/650 mg. The tablets are the generic equivalent to Endo Pharmaceuticals' Percocet ...
Tags: US FDA, ANDA, Watson Pharmaceuticals, Oxycodone and Acetaminophen tablets
Bristol-Myers Squibb and Pfizer have announced the US FDA's approval for Eliquis (apixaban), used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In 2007, Pfizer and Bristol-Myers ...
Tags: US, FDA, Eliquis, patients, nonvalvular atrial fibrillation
Mylan's subsidiary Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phenytoin Chewable Tablets USP, 50 mg. Phenytoin is the generic ...
Tags: Mylan, Mylan Pharmaceuticals, US, FDA, ANDA, Phenytoin Chewable Tablets
The US FDA has approved Abbreviated New Drug Application (ANDA) for Breckenridge Pharmaceutical's rizatriptan benzoate tablets. Following the ANDA approval, the company has also annonunced the immediate launch of the tablets. ...
Tags: US FDA, ANDA, Breckenridge Pharmaceutical, rizatriptan benzoate tablets
Aurobindo Pharma has secured approval from the US FDA to manufacture and market nafcillin for injection USP, packed in 1g and 2g bottles as well as nafcillin for injection USP 10g bottle pharmacy bulk package. Nafcillin, is a sterile ...
Tags: Aurobindo Pharma, market nafcillin, injection USP, pharmacy bulk package
Aegerion Pharmaceuticals' Juxtapid (lomitapide) capsules has received US FDA approval to be used as an adjunct to a low-fat diet and other lipid-lowering treatments. Juxtapid, which is a supplement to fat reduction treatments also ...
Tags: Juxtapid, US, FDA, capsules, treatments
The US FDA has approved the use of Genentech's Tamiflu (oseltamivir phosphate) for the treatment of Influenza in infants aged two weeks and more. Tamiflu works by blocking the ability of the virus to replicate in the body thereby ...
The US FDA has approved Chembio Diagnostics' Dual Path Platform (DPP) point-of-care HIV 1/2 rapid test. The DPP HIV 1/2 assay is developed to detect HIV-1/2 antibodies in either oral fluid or blood samples, which will bind directly with ...
Tags: FDA, HIV, oral fluid, detection reagents