Currently browsing tag

letter

India’s Cadila gets FDA warning for violating standards at 2 plants

India’s Cadila Healthcare Ltd said it had received a “warning letter” from the U.S. Food and Drug Administration for violating manufacturing standards at two of its production sites in India, sending its shares down 15 percent on Thursday. The company said its Moraiya and Ahmedabad facilities have been cited in the letter, and it is working on responding to the FDA concerns regarding the sites. None of Cadila’s products being sold in the United States use any raw materials made at the Ahmedabad plant, it added.

FDA denies approval for Actavis hypertension treatment

(Reuters) – Generic drug maker Actavis Plc said the U.S. health regulator denied an approval for its hypertension treatment, a fixed-dose combination of nebivolol and valsartan. The company said it would review the U.S. Food and Drug Administration’s complete response letter and decide on appropriate next steps. The regulator issues a complete response letter when a new or generic treatment cannot be approved in its current form. Actavis did not give any further details on the contents of the letter.