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news.Bentley Pharmaceuticals has reported five generic product approvals from the Spanish Ministry of Health and an approval for simvastatin from the Irish Medicines Board.
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In Spain, Laboratorios Davur, as well as two other Bentley subsidiaries, Laboratorios Rimafar and Laboratorios Belmac, received approval for alendronate weekly for osteoporosis and bone loss, the generic version of Fosamax, which is currently marketed by Merck & Co.
Laboratorios Davur and Laboratorios Rimafar each received approvals in Spain for cardiovascular products including lovastatin 20mg and 40mg tablets. Lovastatin is marketed in the US by Merck & Co. under the trade name Mevacor, and is prescribed for control of cholesterol levels.
Enalapril in combination with hydrochlorothiazide (HCTZ), an anti-hypertensive medication combined with a diuretic is also approved in Spain. The product is marketed in the US by Merck & Co. under the trade name, Vaseretic. Laboratorios Davur also received product approvals in Spain for glucosamine and aceclofenac. Glucosamine is a treatment for osteoarthritis available over-the-counter in the US, but only by prescription in Spain. Aceclofenac is a non-steroidal anti-inflammatory prescribed as a treatment for diseases including osteoarthritis and rheumatoid arthritis.
In Ireland, Bentley’s subsidiary, Bentley Pharmaceuticals Ireland, received approval to market generic simvastatin. The product will be manufactured at Bentley’s facilities in Spain. Simvastatin is the generic version of Zocor, which is marketed in the US by Merck & Co.