Generics

PRINCETON, N.J. – 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.

NEW DELHI — 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.

DUBLIN — Actavis last week announced that it has reached an agreement with Cephalon to settle all outstanding patent litigation associated with Actavis' generic version of Nuvigil (armodafinil tablets).

ARLINGTON, Va. — 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). 

PEAPACK, N.J. — Greenstone on Tuesday announced the introduction of nadolol tablets to its generic pharmaceutical product line. The drug is available in dosage strengths of 20-mg x 100, 40-mg x 100 and 80-mg x 100.

Greenstone's nadolol is the authorized generic equivalent to Corgard. It's used for the long-term management of patients with angina pectoris and for the treatment of hypertension to lower blood pressure, according to the company.

PITTSBURGH — 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, 50-mg, 100-mg, 200-mg and 400-mg strengths.

This product is the generic version of Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults.

JERUSALEM — 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.

Beginning next month, the company will be led by two commercial business units: global specialty medicines (GSM), established in April 2013; and global generic medicines group (GGM).

JERUSALEM — 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.