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.
Ajanta launches generic Axert
BY DSN STAFF
BRIDGEWATER, N.J. — Ajanta Pharma USA on Tuesday announced the launch of its generic Axert (almotriptan malate) tablets. The drug is indicated for acute treatment of migraine headaches in patients with a history of migraine with or without aura.
Ajanta’s almotriptan malate tablets will be available in 6.25- and 12.5-mg dosage strength.
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