NEW YORK, March 14 (UPI) — U.S. firm Lev Pharmaceuticals said Wednesday it has positive results from a phase 3 trial of its drug for hereditary angioedema.
In its CHANGE study of 71 patients with the condition, the primary endpoint was met, with a median time of 2 hours to sustained relief of symptoms, compared […]
CHESTER, N.J., March 14 (UPI) — Adams Respiratory Therapeutics said Wednesday the U.S. Food and Drug Administration accepted its application for a prescription cough drug.
The new drug application is for 600 mg and 1200 mg oral solid extended-release guaifenesin products for the prescription treatment of cough.
“The FDA has made a threshold determination […]
PITTSBURGH, March 14 (UPI) — Mylan said Wednesday the U.S. Food and Drug Administration granted tentative approval to its generic version of Abbott's Depakote ER.
The tentative approval means Mylan may not launch its generic drug until the patent on Depakote ER expires. Mylan is seeking approval for 250 mg and 500 mg strengths of […]
By OLGA PIERCE UPI Health Business Correspondent
WASHINGTON, March 14 (UPI) — The State Children's Health Insurance Program (SCHIP) this week continued on its halting path toward reauthorization.
About 60 advocates rallied outside the Capitol in favor of continuing the program, and a coalition of insurers, employers, providers and consumer groups called for $60 billion in […]
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