Andrx Corporation has announced that the FDA has approved the marketing of its Abbreviated New Drug Application for TaztiaTM (diltiazem HCl). The extended-release capsules are bioequivalent to Tiazac® (Biovail). This product, a calcium-channel blocker, is indicated to treat hypertension and chronic stable angina. The capsules will be available in strengths of 120, 180, 240, 300, and 360 mg.
The FDA has approved an orphan drug, ambrisentan (Letairis, Gilead), for patients with pulmonary arterial hypertension. This rare, life-threatening condition is characterized by continuous high blood pressure within the arteries of the lungs.
Ambrisentan was granted a priority review. The drug’s safety and effectiveness were demonstrated in two international clinical trials. Ambrisentan significantly improved physical activity capacity, compared with a placebo, in a six-minute walk, and it delayed the worsening of pulmonary hypertension.
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This drug should not be used by pregnant women or by women who might become pregnant. Monthly blood tests are required to check for potential liver injury.
Ambrisentan will be available as 5-mg and 10-mg once-daily tablets. Gilead holds the U.S. rights to this agent; Glaxo-SmithKline holds rights outside the U.S.
The FDA has approved a once-daily tablet combining amlodipine drags (Norvasc), a calcium-channel blocker, and olmesartan medoxomil (Benicar), an angio-tensin-receptor blocker, for the treatment of hypertension drags. In clinical trials, Azor pro duced significant mean reductions in systolic and diastolic blood pressure. When compared with generic amlodipine 10 mg alone, Azor 10/40 mg resulted in a 53% greater reduction in systolic blood pressure.
The FDA has approved a once-daily tablet combining amlodipine drags (Norvasc), a calcium-channel blocker, and olmesartan medoxomil (Benicar), an angiotensin-receptor blocker, for the treatment of hypertension. In clinical trials, Azor produced significant mean reductions in systolic and diastolic blood pressure. When compared with (buy) amlodipine 10 mg alone, Azor 10/40 mg resulted in a 53% greater reduction in systolic blood pressure.
