Namzaric gets FDA approval for expanded label
SILVER SPRING, Md. — Allergan and Adamas Pharmaceuticals on Tuesday announced an expanded label for their Namzaric (memantine and donepezil hydrochlorides). It can now be used by patients with moderate to severe Alzheimer’s disease.
Patients currently stabilized on Aricept (donepezil HCL, 10 mg) can begin combination therapy with Namzaric.
"Namzaric offers the benefits of combining two products that each work differently to treat moderate to severe Alzheimer's disease while at the same time reducing the number of pills a patient and their caregivers need to administer each day," Allergan chief medical officer Dr. Gavin Corcoran, said. "At Allergan, we're proud to continue developing products and supporting new programs that can help patients and their caregivers as they navigate this complex disease."
The expanded label also comes with two new dosage strengths, which the companies said will be available in September.
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.
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