Generics

BRIDGEWATER, N.J. — The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

The FDA approved indomethacin extended-release capsules in the 75-mg strength. The drug is used to treat pain associated with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, bursitis and tendonitis.

ALEXANDRI, Va. — In a letter penned Thursday by the National Association of Chain Drug Stores to Sen. Olympia Snowe, R-Maine, the association stated that while it shares the goal of reducing prescription drug costs, authorizing the reimportation of prescription medications — as sought in S.319, the Pharmaceutical Market Access and Drug Safety Act of 2011 — raises concerns about patient health and safety.

PASADENA, Calif. — Long-term use of a class of drugs used to control pain could increase the risk of erectile dysfunction in men, according to a new study.

The study, sponsored by Kaiser Permanente and published online in the Journal of Urology, found that men who took nonsteroidal anti-inflammatory drugs, or NSAIDs, three times a day for more than three months were 2.4 times as likely to have erectile dysfunction as men who didn’t take the drugs regularly. The study used data from 80,966 men ages 45 to 69 years in California.

WASHINGTON — The head of a group representing the nation's pharmacy benefit managers got honors from the Generic Pharmaceutical Association.

The Pharmaceutical Care Management Association announced Thursday that president and CEO Mark Merritt had received the GPhA’s Outstanding Contribution Award at the generic drug industry group’s annual meeting in Orlando, Fla. The organization has advocated increased generic drug utilization and found common cause with the generics industry in its support for follow-on biologics.

PITTSBURGH — A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

The action is part of the agency’s Unapproved Drugs Initiative, which seeks to remove from the market drugs that have not received approval. In many cases, the drugs were marketed before the FDA adopted its current regulatory standards.

JERUSALEM — Teva on Tuesday said that a trial date has been set for its ongoing patent infringement litigation against several drug makers.

Teva said the U.S. District Court for the Southern District of New York will commence proceedings Sept. 7. Teva's litigation is against Momenta Pharmaceuticals/Sandoz and Mylan Pharmaceuticals/Mylan/Natco Pharma regarding their purported generic versions of Copaxone (glatiramer acetate injection).

PITTSBURGH — Mylan's board of directors now includes the drug maker's president.

Mylan said its board of directors now includes Mylan president Heather Bresch and Robert Cindrich, who currently serves as senior adviser to the office of the president at the University of Pittsburgh Medical Center, a global health enterprise.

With the additions of Bresch and Cindrich, Mylan's board now has 11 members.