NGENLA™ (somatrogon-ghla), is approved by the U.S. Food and Drug Administration as a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. Now approved in over 40 countries worldwide through our partnership with Pfizer, we believe NGENLA™ is poised to transform the human growth hormone treatment landscape by offering patients next-generation innovation.
At OPKO Health, we’ve developed and delivered new medicines that are marketed throughout the world. With our focus on harnessing next-generation solutions by pioneering new advances on proven technologies, our approved therapies are positioned to offer better treatment options for patients.
RAYALDEE® is an extended-release (ER) oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The product is the first and only medicine approved by the U.S. Food and Drug Administration for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH). RAYALDEE is approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency in the U.S. and in 11 European countries.