macitentan

Macitentan (Opsumit®) is a novel dual endothelin receptor antagonist (ERA) that resulted from a tailored drug discovery process with the target to develop an ERA optimized for efficacy and safet...

ATX-MS-1467 for patients with multiple sclerosis (MS)

ATX-MS-1467 is a novel treatment that was developed with the aim of working with the immune system to treat the underlying cause of disease rather than just treating the symptoms or suppressing the...

Brain Cancer

According to the American Brain Tumor Association, just over 24,000 patients will be diagnosed with a primary malignant brain tumour during 2012 in the US alone. Some 80% of primary malignant brain...

Coronavirus

Coronavirus were first identified in the 1960s, and were named after the crown-like projections on the surface of the virus. They cause respiratory infections in both humans and animals. Coronavir...

Generics Drugs - news, views, reports

A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration,...

Teva withdraws generic antidepressant from US

Israel-based Teva Pharmaceutical Industries (Teva), the world’s largest generics manufacturer, has removed its Budeprion XL 300 mg generic version of GlaxoSmithKline’s antidepressant Wellbutr...

FDA Pulls One Generic Form of Wellbutrin Off the Market

By Carina Storrs HealthDay Reporter WEDNESDAY, Dec. 5 (HealthDay News) -- People taking the antidepressant Wellbutrin now have one less option for a generic version of the drug. In Oc...

TevaImpax generic Wellbutrin XL 300mg pulled from US market on non-bioequivalence grounds

Following a review of new data, the US Food and Drug Administration says these indicate that Budeprion XL 300mg (bupropion hydrochloride extended-release tablets), a generic version of UK pharma giant...

Impax, Teva pull generic version of Wellbutrin XL 300 mg

Impax Laboratories Inc. (NASDAQ:IPXL) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) pulled a generic version of antidepressant Wellbutrin XL 300 mg from the market after FDA determined the gener...

Generic antidepressant not equivalent to original Wellbutrin -FDA

Oct 6 (Reuters) - The U.S. Food and Drug Administration said new data indicate that the generic version of the popular antidepressant Wellbutrin is not equivalent to the original drug manufactured by...

Generic antidepressant not equivalent to original Wellbutrin: FDA

(Reuters) - The U.S. Food and Drug Administration said new data indicate that the generic version of the popular antidepressant Wellbutrin is not equivalent to the original drug manufactured by GlaxoS...

Wellbutrin XL bupropion regulatory update

FDA Update: Budeprion XL 300 mg Not Therapeutically Equivalent to Wellbutrin XL 300 mg

October 3, 2012 -- The U.S. Food and Drug Administration (FDA) has reviewed new data that indicate Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laborat...

Unsafe health and safety: sphygmomanometer cuffs are not interchangeable.

Unknown to its hypertension specialists, a major teaching hospital changed the cuffs on its sphygmomanometers from manufacturer-validated to a uniform washable alternative, in line with 'Health and Sa...

Impairing loyalty: corporate responsibility for clinical misadventure.

A medical device manufacturer pays a surgeon to demonstrate a novel medical instrument in a live broadcast to an audience of specialists in another city. The surgical patient is unaware of the broadca...

Outcome of palliative self-expanding metal stent placement in malignant colorectal obstruction according to stent type and manufacturer.

BACKGROUND: Self-expandable metallic stents (SEMS) of varying designs and materials have been developed to reduce complications, but few comparative data are available with regard to the type of stent...

Industry involvement and baseline assumptions of cost-effectiveness analyses: diagnostic accuracy of the Papanicolaou test.

Background Industry involvement has been associated with more favourable cost-effectiveness ratios in cost-effectiveness analyses, but the mechanisms for this association are unclear. We evaluated whe...

Factor VIII Bypassing Activity (FEIBA) assays: standardization and development of the 1st NIBSC Working Standard for FEIBA - results from a collaborative study.

Factor-Eight-Inhibitor-Bypassing-Activity (FEIBA) is a bypassing-agent used to control spontaneous bleeding or cover surgical interventions in Haemophiliacs who develop neutralizing antibodies against...