The FDA has approved Tracleer (bosentan tablets, from Actelion), a dual endothelin receptor antagonist, for the treatment of patients with mildly symptomatic World Health Organization (WHO) Functional Class II pulmonary arterial hypertension (PAH).
The FDA has approved Tyvaso (treprostinil inhalation solution, from United Therapeutics), a prostacyclin vasodilator, for the treatment of pulmonary arterial hypertension (PAH) using the Tyvaso Inhalation System.
The FDA and Nutracoastal Trading LLC have notified healthcare professionals and consumers of a voluntary nationwide recall of Steam, a dietary supplement product.
The FDA has approved an expanded indication for Tekturna HCT (aliskiren/hydrochlorothiazide tablets, from Novartis) to include initial therapy for patients with hypertension who are likely to need multiple drugs to achieve their blood pressure goals.
The FDA is evaluating interim safety findings from the ongoing EXCELS study of Xolair (omalizumab subcutaneous injection, from Genentech and Novartis), that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.
The FDA and Haloteco have notified healthcare professionals and consumers of a voluntary nationwide recall of Libipower Plus. Lab analyses found samples of Libipower Plus to contain undeclared tadalafil, which is an active ingredient of FDA-approved drugs used in the treatment of erectile dysfunction (ED).
The FDA has approved Adcirca tablets (tadalafil, from United Therapeutics), a once-daily oral phosphodiesterase type 5 (PDE5) inhibitor, for the treatment of pulmonary arterial hypertension (PAH).
Essentialis announced that it met its primary endpoint of statistically significant triglyceride reduction in a 90-patient Phase 2b trial of DCCR in dyslipidemic patients.
AstraZeneca has announced that wholesale ordering restrictions in place for Toprol-XL (metoprolol succinate) extended-release tablets have been removed and that supply levels of Toprol-XL are approaching near usual levels.
The FDA has approved Azor (amlodipine/olmesartan medoxomil tablets, from Daiichi Sankyo), a combination product containing a calcium channel blocker and an angiotensin II receptor blocker, as first-line therapy in patients likely to need multiple antihypertensive agents to help control their blood pressure.
