3M Riker's Class I anti-arrhythmic Tambocor (flecainide) received approval from FDA on Oct. 23 for two new indications: prevention of paroxysmal supraventricular tachycardias (PSVT) and paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms but not structural heart disease. Tambocor's use has been limited to documented ventricular arrhythmias that are life-threatening because of the Cardiac Arrhythmia Suppression Trial (CAST) that showed flecainide and encainide (Bristol-Myers Squibb's Enkaid) had a 2.2-fold higher risk of mortality and nonfatal cardiac arrest than placebo. Bristol announced last fall that it planned to remove Enkaid from the market ("The Pink Sheet" Sept. 23, T&G-4). In PSVT clinical trials, 79% of flecainide-treated patients had no attacks compared to 15% of placebo-treated patients. Flecainide also reduced the symptoms of tachycardia, palpitations and dyspnea. The recommended dose for PSVT and PAF patients is 50 mg every 12 hours. Bristol-Myers Squibb received a supplemental approval for a once-daily regimen of Capozide (captopril/hydrochlorothiazide) as first-line treatment of hypertension on Oct. 24. The combination ACE inhibitor/diuretic was initially approved as a second-line treatment for hypertension. Prior to the approval of the once-daily regimen, Capozide labeling recommended either b.i.d. or t.i.d. doses for the treatment of hypertension. Capozide is available in four different capsule strengths: captopril 25 mg/hydrochlorothiazide 15 mg; captopril 25 mg/hydrochlorothiazide 25 mg; captopril 50 mg/hydrochlorothiazide 15 mg; and captopril 50 mg/hydrochlorothiazide 25 mg. Sandoz' benzodiazepine hypnotic Restoril (temazepam) gained new indications for the treatment of transient insomnia and sleep latency. Restoril has been indicated for the relief of insomnia associated with difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Sandoz also received approval for a lower strength of Restoril, 7.5 mg caps.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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