New Prostate Cancer Indication for Lynparza
May 20, 2020Expanded Indication and New Dosage Form for Tivicay
June 12, 2020Some of Latest Drug Approved and Launched News
Expanded Fiasp Indication Allows Use in Insulin Pumps
Fiasp is indicated to improve glycemic control in adults who have diabetes mellitus. Prior to the approval of its newly expanded indication, it was approved for administration via intravenous infusion subcutaneous injection. Approximately 35,000 patients in the United States who use insulin infusion pumps may now be eligible to use Fiasp.
Vumerity Approved to Treat Multiple Sclerosis
The U.S. FDA has approved Vumerity™ (diroximel fumarate) to treat adults who have relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Abrilada Approved as Biosimilar for Humira
Like its reference product Humira® (adalimumab – AbbVie), Pfizer’s Abrilada™ (adalimumab-afzb) is indicated to treat certain patients who have rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, or plaque psoriasis.
First Biosimilar for Rituxan Launched
Teva and Celltrion have announced the launch of Truxima® (rituximab-abbs), the first available FDA-approved biosimilar for Genentech and Biogen’s Rituxan® (rituximab). Like Rituxan, Truxima is approved to treat adults who have certain types of non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL).
Ziextenzo Approved as Biosimilar to Neulasta
Ziextenzo™ (pegfilgrastim-bmez), manufactured by Sandoz, is the third biosimilar for Neulasta® (pegfilgrastim – Amgen) to receive FDA approval. It is indicated to decrease the incidence of infection manifested by febrile neutropenia (FN) in patients who have nonmyeloid malignancies and are receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of FN.