16 documents

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08:00 , Jan 4, 2016 |  BC Week In Review  |  Clinical News

Avandia rosiglitazone regulatory update

FDA removed the REMS for rosiglitazone-containing Type II diabetes drugs. The move comes 5 years after FDA issued the REMS warning of potential increased cardiovascular risk and 8 years after a meta-analysis first implicated GlaxoSmithKline’s...
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07:00 , Mar 27, 2014 |  BC Innovations  |  Distillery Therapeutics

Indication: Pulmonary disease

Indication Target/marker/pathway Summary Licensing status Publication and contact information Pulmonary disease Emphysema Peroxisome proliferation-activated receptor-g (PPARG; PPARg) Ex vivo and mouse studies suggest agonizing PPARg could help...
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08:00 , Jan 28, 2008 |  BC Week In Review  |  Clinical News

Avandia rosiglitazone regulatory update

EMEA's CHMP recommended that a contraindication be added to the label for rosiglitazone-containing Type II diabetes drugs stating that the thiazolidinedione (TZD) PPAR gamma agonist must not be used in patients with an acute...
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08:00 , Nov 19, 2007 |  BC Week In Review  |  Clinical News

Avandia rosiglitazone regulatory update

FDA and GSK plan to supplement the existing boxed warning on the label of Avandia rosiglitazone to include new language noting that it has been associated with a potential increase in the risk of myocardial...
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02:36 , Nov 15, 2007 |  BC Extra  |  Company News

Avandia gets stronger warning

FDA and GlaxoSmithKline (LSE:GSK; GSK) announced Wednesday an agreement to supplement the existing boxed warning for Avandia rosiglitazone to include new language noting that it has been associated with a potential increase in the risk...
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07:00 , Oct 8, 2007 |  BC Week In Review  |  Clinical News

Avandamet rosiglitazone/metformin regulatory update

GSK added a boxed warning to the label for Avandamet rosiglitazone/metformin to warn of the risk of congestive heart failure (CHF) and highlight the fact that the diabetes drug is not recommended in patients with...
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07:00 , Oct 8, 2007 |  BC Week In Review  |  Company News

GlaxoSmithKline, Teva endocrine, generics news

The companies settled a pair of suits filed in the U.S. District Court for the District of New Jersey, in which GSK alleged that TEVA's generic versions of Avandia rosiglitazone and Avandamet rosiglitazone/metformin...
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00:28 , Aug 15, 2007 |  BC Extra  |  Company News

Avandia, Actos get black boxes

FDA said manufacturers of thiazolidinedione diabetes drugs will change the products' labels to include black box warnings against use in patients with heart failure. The warning emphasizes that the drugs may cause or worsen heart...
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07:00 , May 29, 2006 |  BC Week In Review  |  Clinical News

Avandamet rosiglitazone/metformin regulatory update

FDA approved an sNDA for Avandamet as an adjunct to diet and exercise to improve glycemic control in patients with Type II diabetes when treatment with rosiglitazone and metformin therapy is appropriate. The combination of...
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08:00 , Jan 9, 2006 |  BC Week In Review  |  Clinical News

Avandamet rosiglitazone/metformin regulatory update

GSK issued a "Dear Healthcare Provider" letter for Type II diabetes products containing rosiglitazone - Avandia rosiglitazone, Avandamet rosiglitazone/metformin and Avandaryl rosiglitazone/glimepiride - to warn of new onset and worsening diabetic macular edema,...
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