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European regulators approve new drugs at a faster clip than their Canadian counterparts, but both jurisdictions have the same rate of pulling drugs from the market due to safety reasons, a new study finds. Read More
The FDA has cleared Mylan’s generic version of Upsher-Smith’s potassium drug Klor-Con, and the generics firm has already started shipping the product. Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply. Read More
A federal court has ruled that generic manufacturer Mylan does not have to recall its already-shipped versions of Hospira’s sedative Precedex, a move that reverses the court’s earlier mandate to recall all existing generic versions of the drug. Read More
In a widely expected move, the Drug Enforcement Administration has clamped down on misuse of hydrocodone combination products (HCPs) by classifying them as Schedule II controlled substances, a designation that already applies to oxycodone and non-combo hydrocodone painkillers. Read More
Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized this week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents. Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
In an unusual case, Novo Nordisk agreed this week to pay $89,315 to Danish authorities to settle allegations it didn’t disclose the FDA’s rejection of two insulin products fast enough. Read More
Eli Lilly and Boehringer Ingelheim have won tentative FDA approval for their insulin product Basaglar, which is considered the biosimilar of a Sanofi product in Europe but is being reviewed as its own NDA in the United States. Read More