Generics

PRINCETON, N.J. — Sandoz has launched an authorized generic drug for treating a disease commonly known as pre-leukemia, the company said on Monday.

ALLEGAN, Mich. — The Food and Drug Administration has approved a drug made by Perrigo Co. for treating heart disease, the company said Monday.

The FDA approved Perrigo's nitroglycerin lingual spray in the 400-mcg-per-spray strength. The drug is used to relieve attacks of or prevent angina pectoris due to coronary artery disease.

JERUSALEM — Teva Pharmaceutical Industries has launched a generic drug for treating cardiovascular disease, the company said.

Teva announced the launch of niacin extended-release tablets in the 500-mg, 750-mg and 1,000-mg strengths. As the first company to file for approval of the drug, Teva will have 180 days in which to market the generic version exclusively.

ALLEGAN, Mich. — Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said Friday.

The Allegan, Mich.-based drug maker announced the appointment of Keith Webber as head of regulatory review, a position in which he will start on Oct. 21. Webber previously served as acting director of the FDA's Office of Pharmaceutical Science, part of the Center for Drug Evaluation and Research, which regulates prescription and OTC drugs. He also served as director of the Office of Generic Drugs.

WASHINGTON — A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

The healthcare industry has been laser-focused on prevention since it became obvious that stemming the tide of disease in our country required an upstream solution. From tackling prediabetes in adults to preventing childhood disease with infant immunizations, health professionals are onboard — with most finding a way to incorporate disease prevention into everyday practice.   

ARLINGTON, Va. — The Healthcare Distribution Management Association on Wednesday recognized three members of Congress — Sen. Michael Bennet, D-Colo.; Rep. Bob Latta, R-Ohio; and Rep. Jim Matheson, D-Utah — with the association’s Rx Safety and Healthcare Leadership Award. 

The award honors public officials for their leadership and commitment to policies that promote the safe and efficient delivery of lifesaving medicines to patients nationwide.

BALTIMORE — The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

The FDA approved zolpidem tartrate extended-release tablets in the 6.25-mg and 12.5-mg strengths, a generic version of Sanofi's Ambien CR.

The branded version of the drug had sales of $366 million during the 12-month period ended in March, according to IMS Health.