Watson/FDA Consent Decree Will Not Involve Product Recalls, Firm Says
Executive Summary
Watson does not expect to recall any products manufactured at its Corona, Calif. facility as a result of a proposed consent decree with FDA, CEO Allen Chao, PhD, told analysts in a March 28 conference call
You may also be interested in...
Watson consent decree
Watson will hire an outside expert within 45 days to determine whether its "methods, facilities, and controls used at the Corona facility for manufacturing, processing, packing, holding, and distributing drugs are in compliance," the company's May 3 consent decree with FDA states. The first of the expert's annual reports is due in the first quarter of 2003. Watson has two pending ANDAs at the Corona, Calif. facility. As anticipated, Watson will not pay a fine or initiate a recall as a result of the consent decree (1"The Pink Sheet" April 1, p. 23)...
Watson consent decree
Watson will hire an outside expert within 45 days to determine whether its "methods, facilities, and controls used at the Corona facility for manufacturing, processing, packing, holding, and distributing drugs are in compliance," the company's May 3 consent decree with FDA states. The first of the expert's annual reports is due in the first quarter of 2003. Watson has two pending ANDAs at the Corona, Calif. facility. As anticipated, Watson will not pay a fine or initiate a recall as a result of the consent decree (1"The Pink Sheet" April 1, p. 23)...
Watson Oxytrol Approval Expected In 2003; Patch Is “Not Approvable” At FDA
Watson Pharmaceuticals expects the overactive bladder patch Oxytrol to be cleared by FDA in the first quarter of 2003, following receipt of a "not approvable" letter March 26