Lilly, Boehringer Ingelheim get expanded Synjardy indication
SILVER SPRING, Md. — Eli Lilly & Co. and Boehringer Ingelheim announced Tuesday that the Food and Drug Administration had approved an expanded indication for their Synjardy (empagliflozin and metformin hydrochloride) tablets.
The new indication makes the drug available for treatment-naïve adults with type 2 diabetes as an adjunct to diet and exercise as a way of improving glycemic control.
"Type 2 diabetes is a complex condition, which often requires that people take more than one treatment to manage their blood sugar," Boehringer Ingelheim president and CEO Paul Fonteyne said. "The expanded indication for Synjardy further validates the potential of this combination therapy to help adults with type 2 diabetes who are not at goal, including those already being treated and, now, those at the beginning of their treatment journey."
FDA approves Aurobindo’s Vicoprofen generic
Dayton, N.J. — The Food and Drug Administration has approved Aurobindo Pharma’s generic of Vicoprofen (hydrocodone bitartrate and ibuprofen) tablets, the company announced Tuesday. The drug is indicated for short-term management of acute pain.
Aurobindo’s generic will be available in 7.5 mg hydrocodone/200 mg ibuprofen tablets. The product had U.S. sales of about $15.7 million for the 12 months ended May 2016, according to IMS Health.
FDA approves Belviq XR from Eisai, Arena
SILVER SPRING, Md. — The Food and Drug Administration has approved Eisai’s and Arena Pharmaceuticals’ Belviq XR (lorcaserin HCl) extended-release 20-mg tablets, the companies announced Tuesday.
The drug is a new formulation of lorcaserin that can offer patients once-daily dosing and could help maintain weight loss, as it’s indicated for use in patients for chronic weight management. Following the approval, Arena will receive a $10 million milestone payment.
"With approximately two-thirds of the U.S. population living with extra weight or obesity, there is a significant and growing need to address chronic weight management," said Dr. Louis J. Aronne, M.D., principal investigator of the Belviq clinical trials. "Having a once-daily treatment may offer an option for patients to stay on track to meet their weight loss goals."
The companies expect Belviq XR to be available in the fall of 2016.
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