Dr. Reddy’s launches 2 generics
Dr. Reddy’s is introducing sevelamer carbonate for oral suspension, in 0.8 g and 2.4 g packets, after having received approval from the Food and Drug Administration.
The product is the generic of Sanofi’s Renvela (sevelamer carbonate) for oral suspension. It is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease on dialysis.
The Renvela brand and generic had a market value of roughly $101 million for the most recent twelve months ending in October 2018, according to IQVIA.
Dr. Reddy’s also is introducing aspirin and extended-release dipyridamole capsules, having received the Food and Drug Administration’s nod earlier.
The product is the generic of Boehringer Ingelheim’s Aggrenox (aspirin and extended-release dipyridamole) capsules.
The Aggrenox brand and generic had a market value of about $182 million or the most recent twelve months ending in October 2018, according to IQVIA data.
Dr. Reddy’s product is available in 25 mg/200 mg dosage strengths in a 60- count bottle size.
Shire gets FDA’s blessing for Motegrity
The Food and Drug Administration has green lighted Shire’s Motegrity (prucalopride), a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation, or CIC.
Motegrity, a selective serotonin-4 (5-HT4) receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility.
Motegrity is expected to launch in 2019 in the United States where an estimated 35 million adults are living with CIC.
“The approval of Motegrity marks a new day in the treatment of CIC,” Shire senior vice president and chief medical officer Howard Mayer said. “This significant milestone reinforces our continued commitment to the GI community and advances our goal of addressing the unmet need of patients suffering from rare, specialized and common GI conditions.”
Stemline Therapeutics gets FDA green light for Elzonris
Stemline Therapeutics has received the Food and Drug Administration’s approval for Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm, or BPDCN in adults and in pediatric patients, two years of age and older.
BPDCN is an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, including the lymph nodes and the skin. It often presents as leukemia or evolves into acute leukemia. The disease is more common in men than women and in patients 60 years and older.
“Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed by bone marrow transplantation. Many patients with BPDCN are unable to tolerate this intensive therapy, so there is an urgent need for alternative treatment options,” director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, Richard Pazdur said.