Bioniche Pharma launches generic Sandostatin
PITTSBURGH — Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.
Mylan announced the launch of octreotide acetate injection in prefilled syringes, a generic version of Novartis’ Sandostatin, used to treat the disorder acromegaly and suppress or inhibit severe diarrhea related to certain tumors. Acromegaly results from excess growth hormone produced in the pituitary gland, causing fatigue and weakness, body odor and carpal tunnel syndrome.
“This approval is particularly important because it is the first and only [prefilled syringe] for this product — branded or generic — providing hospitals and clinics access to a preferred presentation that offers ease, accuracy and convenience of dosing,” Mylan Institutional president Matt Erick said.
Ocreotide acetate injection had sales of about $579 million in 2010, according to IMS Health.
FDA simplifies food recall search for consumers
SILVER SPRING, Md. — The Food and Drug Administration Tuesday unveiled its easier-to-use search engine for consumers that are concerned about food and other product recalls.
Under the Food Safety Modernization Act, which was signed into law in January, the FDA is required to provide a consumer-friendly recall search engine within 90 days after the law went into effect. Now, the FDA provides search results that include data from news releases and other recall announcements in the form of a table. The FDA also indicates on the site whether the recall is ongoing or completed, a requirement that was put into effect when the FSMA was passed.
Prior to launching the new Web search, the FDA consulted such stakeholder groups as the Center for Science in the Public Interest, Consumers Union, Food Marketing Institute, Grocery Manufacturers Association, the Pew Health Group and Safe Tables Our Priority to gain their insights on how to most effectively and easily communicate recall information to consumers.
"Recalls, mandatory or otherwise, are serious, and we must do everything possible to make it easier for people to know about these recalls so they can take all appropriate steps to protect themselves and their families," said Mike Taylor, FDA deputy commissioner for foods. "We encourage people to check out our new recalls search page for themselves, and use it whenever they have a question about a recall.
"The new search page not only provides consumers with an easy-to-read table of information on products they are searching for; it also represents the delivery of one of the first major actions called for under the Food Safety Modernization Act," Taylor added. "That delivery is on time and right on target, and we appreciate the involvement of our stakeholders."
David Neu named ABDC president
VALLEY FORGE, Pa. — AmerisourceBergen on Monday promoted David Neu, 53, to president of AmerisourceBergen Drug, the company’s largest operating unit, effective immediately. Neu, a 29-year veteran of the company, most recently was SVP operations.
The role of president of AmerisourceBergen Drug previously was held by Steven Collis, currently EVP and COO. Collis recently was named to succeed David Yost as CEO upon Yost’s retirement on July 1. In his new role, Neu will continue to report to Steven Collis.
"Throughout his tenure at AmerisourceBergen, Dave has held several leadership roles within ABDC, and he has been instrumental in both guiding its recent success, and positioning it for future growth," Collis stated. "Dave’s commitment to customers, suppliers and associates, and his experience leading both sales and operational efforts, will enable him to continue to drive value for all of our stakeholders, and to take advantage of the opportunities that lie ahead."