Indian drug maker Wockhardt has been charged by the Food and Drug Administration with utilizing the same unapproved method to test drug quality in its Morton Grove, Ill., facility as two facilities in India, both of which were subsequently banned from importing into the United States,the Wall Street Journal reported Tuesday.
Sandoz on Tuesday announced an agreement with Upsher-Smith to obtain exclusive U.S. distribution rights for its branded potassium chloride line of products, Klor-Con, and market them under the Sandoz name.
HDMA on Tuesday honored pharmaceutical and consumer product manufacturers at its 2014 Business and Leadership Conference in Phoenix, through the presentation of the Association’s annual Distribution Industry Awards for Notable Achievements in Healthcare (the DIANA awards).
Teva Pharmaceutical Industries on Monday announced a new organizational structure and executive positions. The changes, which will become effective July 1, are designed to improve global integration and effectiveness across the company, Teva said.
Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.
Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.