Global pharma major Lupin Limited on Friday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Canagliflozin Tablets, 100 mg and 300 mg. According to a press statement, the approval has been granted to market a generic equivalent of Invokana … Read more
Concerns have been raised over the suitability of current FDA-approved treatments for myelofibrosis due to the negative associations with anemia. In response, the FDA has significantly increased the number of awarded orphan drug designations (ODDs) for myelofibrosis-indicated drugs in recent years. Since 2014, a total of 11 ODDs have been granted, with eight of them … Read more
Bengaluru: The U.S. Food and Drug Administration (FDA) has approved Ardelyx’s drug to treat high phosphate levels in patients with chronic kidney disease (CKD), the company said on Tuesday, more than two years after it was initially rejected. The drug, branded as Xphozah, was approved to treat hyperphosphatemia, a condition resulting in an abnormally elevated … Read more
Global pharma major Lupin Limited recently announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg. Approval is granted to market a generic equivalent of Erleada Tablets, 60 mg of Janssen Biotech, Inc. This product will be … Read more