Posted on 22 July 2009
Tags: aliskiren, amlodipine, Diovan, diuretic hydrochlorothiazide, FDA, Novartis, Rasilez, renin inhibitor, Tekturna HCT, valsartan
FDA approved Novartis’ Tekturna HCT® tablets as initial therapy for hypertensive patients likely to need multiple blood pressure medications. The drug is a single-pill combination of the direct renin inhibitor, aliskiren (Tekturna/Rasilez), and the diuretic hydrochlorothiazide (HCT).
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Tekturna HCT was first approved in the U.S. in January 2008 as a second-line treatment for high blood pressure, and in the EU in January 2009. Novartis says that it is also developing other single-pill aliskiren combinations including a combination with Diovan (valsartan) and one with amlodipine.
The single-agent direct renin inhibitor, Tekturna, was first approved in March 2007 and is now available in over 70 countries. Most recently in July 2009 it entered Japan.
Source: GEN News
Popularity: 3% [?]
Posted on 06 February 2009
Tags: Abilify, aripiprazole, Bristol Myers Squibb, Diovan, FDA, haemolytic anaemia, Lamisil, Novartis, orlistat, Roche, schizophrenia, terbinafine, valsartan, Xenical
The FDA released the third quarterly installment of a list of drugs that it is currently reviewing over potential safety issues. The agency specified that if a product appears on the list, “it means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk.”
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According to the information available on the agency’s site, among other compounds, the FDA is reviewing the safety of Roche’s weight-loss drug Xenical (orlistat) over concerns about the risk of rectal bleeding in patients receiving the drug. Novartis’ fungal treatment Lamisil (terbinafine) is being reviewed for potential links to psychiatric events and the drugmaker’s hypertension drug Diovan (valsartan) is being examined over concerns about haemolytic anaemia. Furthermore, the agency is investigating the risk of birth defects in babies born of women administered antidepressants and is also examining Bristol-Myers Squibb’s schizophrenia compound Abilify (aripiprazole) over potential concerns about liver toxicity.
The agency, which has already announced safety reviews for many of the products that appear on the list, posted the data to its website as part of its ongoing examination of potential adverse drug reactions.
Source: FirstWord
Popularity: 6% [?]
