The Atlanta, Georgia-based Sciele Pharma, Inc. has bagged US Food and Drug Administration (FDA) approval for the company's all four dosage strengths of the new Sular formulation. The new Sular formulation, which utilises SkyePharma's patented Geomatrix technology, provides a lower dose of Sular for each of its current doses. The company is expected to launch the new Sular formulation during the first quarter of 2008.
Patrick Fourteau, chief executive officer, Sciele Pharma, said, "We are excited about this approval by the FDA for the new Sular formulation. This validates our product development and regulatory capabilities, as we have become a fully integrated pharmaceutical company.
"Sciele Pharma, Inc. is a pharmaceutical company specialising in sales, marketing and development of branded prescription products focused on cardiovascular/metabolic, women's health and paediatrics. The company's cardiovascular/metabolic products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and type 2 diabetes.
SkyePharma, using its proprietary drug delivery technologies, develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The company has eleven approved products in the areas of oral, inhalation and topical delivery.
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