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The generic drug industry wants the FDA to ensure new requirements for packaging and technologies aimed at curbing opioid abuse don’t result in barriers to market entry for generic makers. Read More
Teva is still fighting to keep generic versions of its blockbuster multiple sclerosis drug Copaxone off the market, with its seventh citizen’s petition asking the FDA to mandate that any ANDA on the product undergo extra levels of bioequivalence testing. Read More
Tramadol manufacturers have approximately 45 days to implement new labeling and security procedures now that the Drug Enforcement Administration has determined the opioid analgesic is a Schedule IV controlled substance. Read More
Indian generics maker Lupin Pharmaceuticals is being sued by Valeant Pharmaceuticals subsidiary Bausch + Lomb and Senju Pharmaceuticals over its ANDA for Prolensa eye drops. Read More
Manufacturers of generic versions of cholesterol drugs Darvocet and Darvon can’t be held liable for not changing their labels to note safety warnings without prior FDA approval, an appeals court has ruled, further entrenching generic drugmakers’ protections from failure-to-warn and other lawsuits. Read More
In a reversal of its 2010 guidance, the UK's cost-benefit watchdog now recommends coverage of Novartis' cancer drug Glivec in some patients following surgery for gastro-intestinal stromal tumours (GIST).
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The U.S. Patent and Trademark Office's recently established patent review board has received what appears to be its first challenge to a drug patent covering a business practice rather than a drug's attributes. Read More
Bills introduced in four states would grant terminally ill patients access to post-Phase-I experimental drugs without having to go through the FDA. Read More
Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. Read More