Cardiovascular diagnostics developer BG Medicine has filed a 510(k) Premarket Notification with the US Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay. Used with Abbott's fully automated ...
Roche has gained FDA approval for the new HIV viral load test, the COBAS TaqMan HIV-1 Test, v2.0, and will launch the product in the US, later in 2012. The COBAS TaqMan HIV-1 Test, v2.0, targets two highly conserved regions of the HIV-1 ...
ADA Medikal has entered into an agreement to distribute BSD Medical's MicroThermX Microwave Ablation line of products in the Turkish market. The mobile MicroThermX system includes a microwave generator, single-patient-use disposable ...
Tags: mobile MicroThermX system, Turky distribution, clinical technology
Pfizer has won US FDA approval for its rheumatoid arthritis (RA) therapy, Xeljanz (tofacitinib citrate) 5mg twice daily, indicated for patients who failed to respond to methotrexate. Xeljanz can be used as a single treatment regime or as ...
Tags: Pfizer, tofacitinib citrate, Xeljanz
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has gained FDA abbreviated new drug application (ANDA) approval for Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg). The Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg) ...
Tags: ONE DOSE, levonorgestrel tablet, Watson Pharmaceuticals
Global pharmaceutical company Sucampo has received a supplement approval from the US Food and Drug Administration (FDA) for updates to AMITIZA (lubiprostone) pregnancy labeling. The approval removes pregnancy 'warnings and precautions' ...
Tags: pharmaceutical, supplement, labeling, lubiprostone, FDA, labeling changes
Supernus Pharmaceuticals has received approval from the FDA for its Oxtellar XR, a new once-daily extended release formulation of oxcarbazepine. Oxtellar XR is an antiepileptic drug used as an adjunct therapy to treat partial seizures in ...
Tags: oxcarbazepine, FDA approval, partial seizure, pharmaceutical product
EvaluatePharma has unveiled a new service enhancement, Tracking Drugs@FDA, which provides clients access to the entire approved FDA drugs, related FDA document library and FDA Orange Book patent data. Tracking Drugs@FDA and Orange Book ...
Tags: EvaluatePharma, Tracking Drugs@FDA, ANDA
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application (ANDA) of Trospium Chloride Extended-release Capsules. Watson anticipates beginning the shipment of the ...
Tags: FDA, Trospium Chloride Extended-release Capsules, pharmaceutical product
Janssen Research & Development company has submitted bedaquiline (TMC207) new drug application (NDA) to the US Food and Drug Administration (FDA) for approval. Bedaquiline,an investigational drug administered orally,is used as part of ...
Tags: FDA, new drug application, investigational drug, pulmonary
CytoDyn has entered into an agreement to purchase Progenics Pharmaceuticals' proprietary humanized monoclonal antibody HIV viral-entry inhibitor drug candidate, PRO 140, for $3.5m. Upon successful continued clinical development of PRO ...
Tags: CytoDyn, HIV viral-entry inhibitor drug, humanized monoclonal antibody
Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary ...
Daiichi Sankyo has gained FDA approval to package product at its packaging facility located in Bethlehem, Pennsylvania, US. The Pennsylvania facility will package some of the company's products for cardiovascular and metabolic ...
Tags: FDA, medical product, expansion, business operations
Ventana Medical Systems has received FDA approval for the application of its INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH) on the BenchMark ULTRA automated slide staining platform. The BenchMark XT instrument, the HER2 ...
Mylan has launched Lithium Carbonate Extended-release Tablets USP, 450 mg following the final approval from the US Food and Drug Administration (FDA). The drug is used to treat manic episodes of manic depressive illness. According to ...
Tags: Mylan, lithium carbonate extended-release tablets, treat manic episodes