FDA NEWS

FDA warns Covidien about plant problems - Reuters
WASHINGTON (Reuters) - U.S. regulators have warned health-care products maker Covidien Ltd about manufacturing problems at a plant in Missouri, a letter released on Tuesday said. The Food and Drug Administration in an August 12 letter said inspectors
Source: www.reuters.com

Ranbaxy AIDS Drug Won't Be Funded by U.S. After FDA Inspection - Bloomberg
Sept. 25 (Bloomberg) -- AIDS drugs made by Ranbaxy Laboratories Ltd. won't be purchased under an American program to supply medicines to developing countries after the U.S. cited the company for violations in two of its plants. The President's
Source: www.bloomberg.com

Sepracor sees FDA filing by late 2008, early 2009 - Boston Globe
MARLBOROUGH, Mass.— Sepracor Inc. said Wednesday it expects to ask the Food and Drug Administration for approval of an epilepsy drug candidate by the end of 2008 or early 2009. The drug is licensed from Portugal-based Bial. Sepracor said it is
Source: www.boston.com

US FDA warns Covidien about plant problems - Forbes
WASHINGTON (Reuters) - U.S. regulators have warned health-care products maker Covidien Ltd about manufacturing problems at a plant in Missouri, a letter released Tuesday said. The Food and Drug Administration in an Aug. 12 letter said inspectors
Source: www.forbes.com

I-Flow Gets 510(k) Approval From FDA for Oxygenated Topical Dressing - RTT News
(RTTNews) - Wednesday, provider of low-cost drug delivery systems and surgical products I-Flow Corporation (IFLO: News ), through its wholly owned subsidiary AcryMed Inc., announced that it has received 510(k) clearance from the US Food and Drug
Source: www.rttnews.com

FDA cracks down on unapproved drugs - Philadelphia Inquirer
WASHINGTON - Federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks. The eye wash, known as
Source: www.philly.com