Impax Laboratories Inc

Impax Laboratories Inc. on Wednesday won tentative regulatory approval for a generic version of Schering-Plough Corp.'s allergy drug Claritin-D, sending its shares up 3.8%. Final Food and Drug Administration approval depends on the outcome of a patent lawsuit Schering-Plough brought against Impax, the expiration of a stay preventing approval of a generic for 30 months when a patent-infringement suit is filed and the expiration of any generic marketing exclusivity, Impax said. Rival Andrx Corp.

Impax Laboratories Inc. on Wednesday said U.S. regulators gave tentative approval to its copy of Purdue Pharma's OxyContin, a painkiller that has been the subject of more than 100 consumer lawsuits claiming it is addictive. Impax, which specializes in making controlled-release generic drugs, still needs to win a patent lawsuit brought by closely held Purdue Pharma and wait for the expiration of any generic marketing exclusivity, the Hayward, Calif.-based company said.

Impax Laboratories Inc. on Wednesday said U.S. regulators gave tentative approval to its copy of Purdue Pharma's OxyContin, a painkiller that has been the subject of more than 100 consumer lawsuits claiming it is addictive. Impax, which specializes in making controlled-release generic drugs, still needs to win a patent lawsuit brought by closely held Purdue Pharma and wait for the expiration of any generic marketing exclusivity, the Hayward, Calif.-based company said.

Impax Laboratories Inc. on Wednesday won tentative regulatory approval for a generic version of Schering-Plough Corp.'s allergy drug Claritin-D, sending its shares up 3.8%. Final Food and Drug Administration approval depends on the outcome of a patent lawsuit Schering-Plough brought against Impax, the expiration of a stay preventing approval of a generic for 30 months when a patent-infringement suit is filed and the expiration of any generic marketing exclusivity, Impax said. Rival Andrx Corp.

A cheaper, generic version of GlaxoSmithKline's Wellbutrin XL antidepressant is just as safe and effective as the original drug, despite complaints from some patients, the Food and Drug Administration said. The FDA said it received 85 reports from patients who switched from Wellbutrin XL to a cheaper generic by Teva Pharmaceutical Industries and Impax Laboratories Inc., including 78 who said they slipped back into depression. Agency scientists reviewed versions of the two drugs and found the data did not show the problems stemmed from any differences between them.

Biovail Corp. reached a settlement with four generic-drug makers that delays sales of cheaper copies of one form of its antidepressant Wellbutrin XL until next year. The deal resolves complaints against Anchen Pharmaceuticals, Impax Laboratories Inc., Teva Pharmaceutical Industries Ltd. and Watson Pharmaceuticals Inc., Mississauga, Canada-based Biovail said Monday. Biovail reported $302.2 million in Wellbutrin XL sales for the first nine months of 2006, or 42% of the company's product revenue.