Generics

PITTSBURGH — The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.

Mylan announced the approval of acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a version of Bayer’s Precose, used with diet and exercise to improve glycemic control in adults with Type 2 diabetes.

The drug had sales of around $23 million during the 12-month period ended in September, according to IMS Health.

HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.

THOUSAND OAKS, Calif. — Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.

BOSTON — Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

The CSDD called the study the first systematic look at REMS since the FDA introduced the program in 2008. The FDA requires drug companies to create a REMS when the agency decides it is necessary to ensure that a drug’s benefits outweigh its risks.

SILVER SPRING, Md. — The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

SAN FRANCISCO — Though it plans to announce its fiscal year 2010 results next month, Watson Pharmaceuticals offered a peak at some preliminary numbers at the 29th annual J.P. Morgan Healthcare Conference Wednesday.

Watson said that based on a review of results for last year, it expects to have earned revenues of more than $3.5 billion, a 25% increase over 2009.

ALEXANDRIA, Va. — The nation’s top independent pharmacy group is hailing a recent decision by a major corporation to maintain freedom of choice of where its employees fill their maintenance prescription medicines.

The National Community Pharmacists Association today applauded BB&T's decision to reemphasize and continue its employees' choice in filling their maintenance prescriptions, including at independent community pharmacies. The revised policy was communicated to BB&T employees last week.

WOONSOCKET, R.I. — While a majority of physicians are comfortable with generic medications, there is a small segment who still have negative perceptions about the effectiveness and quality of generic drugs, and that may lead to doctors prescribing unnecessarily expensive medications, according to a new study by researchers at Harvard University, Brigham and Women's Hospital and CVS Caremark.