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The European Medicines Agency has confirmed plans to halt sales of 700 drug forms and strengths authorized based on clinical studies performed by Hyderabad, India-based GVK Biosciences. Read More
A federal appeals court Friday affirmed a lower court order preventing Actavis from replacing an older formulation of Namenda ahead of generic versions of the Alzheimer’s drug hitting the market in July. Read More
The FDA is hoping that a study of spousal communication related to direct-to-consumer prescription drug advertising will help it make better recommendations for these ads. Read More
The FDA has hit Actavis with a warning letter for making unsubstantiated claims about its Rapaflo benign prostatic hyperplasia drug on a company webpage. Read More
Johnson & Johnson will be liable for unlimited punitive damages in a bellwether trial next month alleging that Extra Strength Tylenol triggered acute liver failure leading to a woman’s death, under a federal court ruling. Read More
The FDA plans to issue a proposed rule this year streamlining requirements for fixed-dose combination prescription and over-the-counter drugs into one set of regulations, according to an updated list of priorities released Friday. Read More
California-based Amgen may soon be the first to get a new class of cholesterol-lowering biologics onto the European market, following a positive opinion from the European Medicines Agency on Friday. Read More
The majority of fixed-dose combination analgesics and antipsychotics on the Indian market have never been approved, leading to the sale of millions of doses of unsafe drugs, a new study concludes. Read More
Toronto, Canada-based Intellipharmaceutics expects to file an NDA for its opioid painkiller Rexista XR within the next year, after receiving notification from the FDA that it won’t need to conduct Phase III clinical trials. Read More
Akorn Pharmaceuticals is voluntarily recalling more than 362,000 units of sulfamethoxazole/trimethoprim oral suspension because the sulfamethoxazole portion doesn’t dissolve in liquid. Read More
In observance of the Memorial Day holiday, Drug Industry Daily will not be published Monday, May 25. The next issue will be published Tuesday, May 26. Read More