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Barr Pharmaceuticals and its subsidiary Pliva have won final FDA approval to manufacture and market injectable azithromycin, a generic version of Pfizer's Zithromax.
The FDA acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued.
The FDA acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued late yesterday.
Barr Pharmaceuticals and its subsidiary Pliva have won final FDA approval to manufacture and market injectable azithromycin, a generic version of Pfizer’s Zithromax.
GlaxoSmithKline (GSK) drug Wellbutrin XR has received a marketing license in the Netherlands, making it the first antidepressant of its kind to be approved in Europe, the company announced.
Drug companies will increasingly outsource their clinical trials in the coming years, with “many top pharmaceutical companies” expecting to do up to 65 percent of their clinical trials abroad, according to the “Outlook 2007” survey by the Tufts Center for the Study of Drug Development (CSDD).
Ranbaxy Pharmaceuticals won final FDA approval to market atenolol, a generic version of AstraZeneca’s hypertension drug Tenormin, the company announced Jan. 2.