He further pointed out that previous studies have shown that some FDA-approved drugs inhibit CYP monooxygenases, including Micardis
, a blood pressure medication, and Lopid, which is used to lower cholesterol.
The settlement alleges that the company misrepresented its antiplatelet drug, Aggrenox, that was effective for many conditions 'below the neck,' such as heart attacks and congestive heart failure, and that it was superior to Plavix, without evidence to substantiate that claim; misrepresented that Micardis
protected patients from early morning strokes and heart attacks and treated metabolic syndrome; misrepresented that Combivent could be used as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD); Falsely stated that Atrovent and Combivent could be used at doses that exceeded the maximum dosage recommendation in the product labelling and that the drugs were essential for treatment of COPD.
The agency has approved its ANDA for telmisartan and hydrochlorothiazide tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg and 80 mg/25 mg, declaring it bioequivalent and therapeutically equivalent to Boehringer-Ingelheim GmbH's Micardis
, 80 mg/pill) was purchased from Boehringer Ingelheim International GmbH Z10980043 (Import Drug License: H20090416, H20090417).
Boehringer Ingelheim et Biopharm ont procede, hier, a Alger au lancement de la production en Algerie de Micardis
, un medicament destine a lutter contre l'hypertension arterielle dont la fabrication est prevue au laboratoire de Biopharm, a Oued Smar.
(valsartan); action of Micardis
angiotensin, the (telmisartan); and vessel-constricting Cozaar (losartan).
Interestingly, the agency overruled "no" votes only three times: (Tarceva for maintenance therapy in lung cancer, Avastin for breast cancer, and Micardis
to lower blood pressure.) Since their approval, these medicines have saved, extended, and improved hundreds of thousands of lives.
Two drugs, telmisartan (Micardis
) and valsartan (Diovan) were found to do a better job than three others--candesartan (Atacand), irbesartan (Avapro) or losartan (Cozaar)--at reducing hospital admissions for heart attack, heart failure and stroke in 54,000 Ontario seniors with diabetes.
Some commonly prescribed drugs in this class are candesartan (Atacand), eprosartan (Teveten), irbesarten (Avapro), losartan (Cozaar), telmisartan (Micardis
) and valsartan (Diovan).
The DOJ announced yesterday that Boehringer will pay $95 million to resolve the allegations that it improperly promoted its anti-stroke drug Aggrenox, its chronic obstructive pulmonary disease drugs Atrovent and Combivent, and its hypertension drug Micardis
. According to the DOJ, Boehringer marketed Aggrenox, for example, to treat certain types of heart problems when it was only approved to prevent strokes.
There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis
), and eprosartan (Teveten).