Tag Archives: FDA

FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market

FDA has reported that it notified Ranbaxy Laboratories, Ltd., on Jan. 23 that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January […]
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Momenta CEO Rebuffs Teva's Copaxone Defense

Momenta Pharmaceuticals’ CEO Craig Wheeler said comments made by Teva leadership about a “purported” generic of Copaxone are “kind of humorous.” Teva’s Copaxone, a multiple sclerosis drug that earns nearly $4 billion a year, is approaching patent expiry – and possible generic competition – on May 24. Assuming FDA approves a generic version of Copaxone, […]
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FDA Gets More Funding, IPAB Gets Less

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays, the Food and Drug Administration did fairly well in gaining additional funds, along with user fee revenues that had been put on […]
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FDA Rolls Out Social Media Guidance — Slowly

Pharma marketers have been clamoring for clear advice from the Food and Drug Administration on how to accommodate established rules governing drug promotion to today’s world of internet communications and social messaging. Now, a guidance from the agency’s Office of Prescription Drug Promotion (OPDP) —and its counterparts for biologics and animal drugs — outlines agency […]
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FDA Approves Fewer New Drugs, But Acts Fast on Innovative Products

FDA Approves Fewer New Drugs, but acts fast on innovative products As expected, the Food and Drug Administration approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near-record of 39 innovative new drugs approved in 2012. In addition, the Center for […]
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