FDA Move Hits GlaxoSmithKline - TheStreet


(GSK) - Get Report

shares fell Friday after the U.K. drugmaker said U.S. regulators had halted distribution of two of its drugs because of "manufacturing issues."

The drugs -- Avandamet for type 2 diabetes and Paxil CR for depression and anxiety disorders -- failed to meet Food and Drug Administration quality-control standards and do not present a significant health hazard, according to the agency.

Glaxo said it also "believes that the manufacturing issues do not pose a health risk to patients," adding that it agreed "with the FDA that patients who use these two medicines should continue taking their tablets and talk with their health care provider if they have questions." The company is working with the FDA to resolve the issues as quickly as possible.

The FDA action applies to all strengths of the two drugs.

Shares $1.03, or 2%, to $49.47.