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FDA approves Warner Chilcott ulcerative colitis drug
DUBLIN — The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.
Warner Chilcott announced the approval of mesalamine in the 400-mg strength.
The company plans to market the drug under the brand name Delzicol and launch it in March.
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FDA gives tentative approval to Dr. Reddy's hypertension drug
SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.
The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.
The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.