Pfizer Inc. received a request for documents as part of a U.S. investigation related to quality issues involving the manufacture of auto-injectors at the company’s Meridian Medical Technologies site.
U.S. FDA Approves Kaléo’s AUVI-Q 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children
Privately held pharmaceutical company kaléo announced that the U.S. Food and Drug Administration approved its supplemental New Drug Application for AUVI-Q (epinephrine injection, USP) 0.1 mg.
Adamis Pharmaceuticals Corp. received U.S. approval for its emergency epinephrine syringes to treat severe allergic reactions that the company intends to be a lower cost rival to Mylan NV’s widely used EpiPen, sending its shares up more than 50 percent.
Mylan NV said U.S. antitrust authorities had launched an investigation into its EpiPen emergency allergy treatment.
Mylan NV has yet to reach a settlement with the U.S. Department of Justice over the classification in the Medicaid program of its life-saving EpiPen allergy treatment, according to a regulatory agency.
Privately held drugmaker Kaleo Inc. announced plans for a U.S. relaunch of its Auvi-Q injector for life-threatening allergic reactions in the first half of 2017.
Mylan NV will pay $465 million to settle questions of whether it underpaid U.S. government healthcare programs by misclassifying its EpiPen emergency allergy treatment.
Teva Pharmaceutical Industries hopes to win U.S. approval by late 2017 or early 2018 for its version of Mylan’s EpiPen device to treat severe allergic reactions.
Mylan NV said it would reduce the out-of-pocket cost of its severe allergy treatment EpiPen through a discount program after lawmakers criticized the drug’s high price.