The FDA issued a warning letter to Tramadol US, calling on the company to stop selling prescription drugs, including opioids, directly to consumers on the 25 websites the company operates.…
Indivior must face a federal jury over allegations that it tried to maintain its monopoly on Suboxone by switching to a sublingual formulation just as other companies were launching generic…
Novartis spin-off Alcon will pick up Aerie Pharmaceuticals, expanding Alcon’s eye care products focus into the prescription pharmaceuticals arena. Source: Drug Industry Daily
Days after announcing a bankruptcy filing to restructure more than $8 billion in debt, Endo International has lost a long-contested patent lawsuit, piling more woes on the beleaguered company. Source:…
The role of FDA advisory committees is “malleable” and the public would trust the FDA more if the agency aligned its decisions on drug approvals with the decisions by the…
Morton Grove Pharmaceuticals (MGP), a division of Mumbai, India-based generics maker Wockhardt, is shutting down operations at its plant in a suburb of Chicago after receiving a court order from…
A Delaware federal judge has ruled that a planned generic from Teva Pharmaceuticals infringes on a patent on Vifor Fresenius Medical Care Renal Pharma’s Velphoro (sucroferric oxyhydroxide), a chewable tablet…
Indian generic drugmaker Sun Pharmaceuticals drew an FDA Form 483 for allegedly falsifying internal documents covering batch records, among other deficiencies, following an agency inspection of the company’s plant in…
The FDA has revised its 2016 draft guidance on charging patients for drugs under investigational new drug applications (IND) in clinical trials or expanded access programs. The updates, which pertain…
The FDA’s accelerated approval program has come under fire again, this time from a group of researchers that found only 38.9 percent of new drugs green-lighted via accelerated approval demonstrated…