The U.S. FDA issued a warning letter to Imprimis Pharmaceuticals Inc. accusing it of making false or misleading claims that its compounded eye medications had the agency’s approval.
Mixed results from two late-stage studies testing Kala Pharmaceuticals Inc.’s drug to provide temporary relief from dry eye disease cast doubt on the drug’s path forward.
2018 opened with elevated U.S. prices on dozens of medicines, but early data showed the increases generally remained within a 10 percent self-imposed limit.
Sun Pharmaceutical Industries Ltd. announced the U.S. FDA accepted a New Drug Application (NDA) for OTX-101 (cyclosporine A, ophthalmic solution) 0.09%.
Allergan Plc tried to reassure shareholders after losing a major patent ruling during October 2017 on its second-most important drug, the dry-eye treatment Restasis, downplaying the importance of the loss of revenue from the drug.
Shares of Imprimis Pharmaceuticals sky-rocketed as much as 91.1 percent after the company said it would offer a cheaper option to Allergan’s dry eye disease medicine Restasis.
A U.S. judge’s ruling invalidating Allergan Plc’s patents on its blockbuster $1.5 billion dry-eye medicine Restasis has cast doubt on the company’s novel strategy to enlist a Native American tribe to help shield those patents from challenge by generic drugmakers, legal experts said.
Allergan Plc said it reached a settlement with InnoPharma Inc., one of the four generic drugmakers challenging the patents for its dry eye medication Restasis in federal court.
Allergan Plc was sued by Shire Plc for allegedly scheming to block doctors from prescribing its new treatment for dry eye disease.
A Native American tribe holding patents for drugmaker Allergan Plc moved to dismiss a case brought by generic drug company Mylan NV challenging the patents.