Global Reach Health – Page 89 – Global Reach Health

December 12, 2019

Xeljanz XR Receives New Indication for Ulcerative Colitis

December 12, 2019 – The U.S. FDA has approved a new indication for Xeljanz® XR (tofacitinib) 11mg and 22mg extended-release tablets, manufactured by Pfizer. Xeljanz XR is now approved to treat moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response or are

December 12, 2019

Vyondys 53 Approved for Duchenne Muscular Dystrophy

December 12, 2019 – The U.S. FDA has approved Vyondys 53TM (golodirsen) injection, manufactured by Sarepta Pharmaceuticals, to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene amenable to exon 53 skipping. Approximately 8% of DMD patients are eligible

December 10, 2019

First Afinitor Generic Launched

December 10, 2019 – Par Pharmaceuticals has launched the first generic for Novartis’s Afinitor® (everolimus) tablets. Everolimus is indicated to treat certain patients who have breast cancer, neuroendocrine tumors, renal cell carcinoma (RCC), or tuberous sclerosis complex (TSC).

December 9, 2019

Jadenu Generics Available

December 9, 2019 – The U.S. FDA has approved generics from multiple manufacturers, including Alembic Pharmaceuticals and Dr. Reddy’s, for Novartis’s Jadenu® (deferasirox) film-coated tablets. Deferasirox is indicated to treat chronic iron overload due to blood transfusions in patients who are at least two years

December 6, 2019

Avsola Approved as Remicade Biosimilar

December 6, 2019 – The U.S. FDA has approved AvsolaTM (infliximab-axxq), manufactured by Amgen, as a biosimilar for Janssen’s Remicade® (infliximab). It is the fourth Remicade biosimilar to receive FDA approval. Like Remicade, Avsola is approved to treat certain patients who have rheumatoid arthritis

December 6, 2019

First Generics Approved for MS Drug Gilenya

December 6, 2019 – The U.S. FDA has approved the first generics for Novartis’s Gilenya® (fingolimod), which is approved to treat relapsing forms of multiple sclerosis (MS) – including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease – in patients who are at

December 3, 2019

New Lung Cancer Indication for Tecentriq

December 3, 2019 – The U.S. FDA has approved a new indication for Tecentriq® (atezolizumab), manufactured by Genentech. The product is now indicated for use in combination with chemotherapy (paclitaxel protein-bound and carboplatin) to provide first-line treatment of metastatic non-squamous

December 2, 2019

Ogivri Launched as Herceptin Biosimilar

December 2, 2019 – Mylan and Biocon have announced the launch of OgivriTM (trastuzumab-dkst), a biosimilar for Roche’s Herceptin® (trastuzumab). It is the second Herceptin biosimilar to be launched on the U.S. market. The first was Amgen’s KanjintiTM (trastuzumab-anns), which launched in June 2019.