Aurobindo's Generic Sevelamer Hydrochloride Receives Approval in the U.S.
We are glad to share that the US DMF for Sevelamer Hydrochloride was successfully submitted to the USFDA. We have a distinctive advantage
Unicycive Therapeutics has laid the groundwork for entering a market targeted by Sanofi and Takeda, posting pivotal bioequivalence data on a candidate designed to improve compliance with kidney disease treatment regimens.
Drug maker Lupin on Tuesday said it has launched Sevelamer Hydrochloride tablets (800 mg), used to treat hyperphosphatemia in patients with chronic kidney disease, in the US market. The company has launched the product after having received approval from the US Food and Drug Administration (USFDA).
Lupin`s Generic Sevelamer Hydrochloride Receives Approval In US
Lupin announced that it has received approval for its Sevelamer Hydrochloride Tablets, 400 mg and 800 mg from the United States Food and Drug Administration to market a generic equivalent of Renagel Tablets, 400 mg and 800 mg, of Genzyme Corporation. The product will be manufactured at Lupin’s facility in Nagpur, India.
FREMONT, Calif. and WALTHAM, June 7, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced two presentations highlighting new tenapanor data at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress 2021, taking place June 5-8, 2021.
New Delhi: Glenmark Pharmaceuticals Monday said it has received final approval from the US health regulator for Sevelamer Hydrochloride tablets, used to control serum phosphorus in patients with chronic kidney disease on dialysis. The approved product is a generic version of Genzyme Corporation's Renagel tablets.
With competition to its diabetes and cardiovascular franchises hurting Sanofi, CEO Olivier Brandicourt pledged a return to growth starting from the second half of 2018. And thanks mainly to Dupixent and now-recovered vaccines sales, he kept his word.