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Generic firms Barr Pharmaceuticals and Dr. Reddy’s Laboratories won FDA approval to market ondansetron, a generic version of GlaxoSmithKline’s Zofran ODT indicated for the prevention of nausea and vomiting associated with cancer chemotherapy.
The FDA approved abbreviated new drug applications filed by six generic drugmakers, allowing them to market generic versions of Merck’s cholesterol treatment drug Zocor.
The FDA approved only two new drug applications (NDAs) in November, but the approval rate is up overall compared with this time last year, according to a report from Friedman Billings Ramsey (FBR).
Generic drug firm Barr Pharmaceuticals is seeking FDA approval to market thalidomide, a generic version of Thalomid, a skin defect drug manufactured by Celgene, Barr announced, Dec. 26.
Northfield Laboratories reported preliminary results from a Phase III clinical trial of its blood substitute, PolyHeme, which showed more deaths among patients using the product than in the control group.
VaxGen said that HHS has terminated for default the company’s $877.5 million contract to provide 75 million doses of a modern anthrax vaccine for civilian biodefense.
The FDA rejected Genta’s new drug application (NDA) for Genasense plus chemotherapy in patients with chronic lymphomatic leukemia (CLL), the company announced.
The FDA is maintaining the clinical hold it imposed Nov. 3 on VaxGen’s Phase II clinical trial for its next-generation anthrax vaccine, the company announced.
Anchen Pharmaceuticals won final FDA approval to be the first to market bupropion hydrochloride extended release, a generic version of Biovail’s antidepressant drug Wellbutrin XL.
Merck continues to predict growth in its earnings per share (EPS) for 2007, due to high expectations for its new products and savings from a global restructuring plan. Read More