FDA approves painkiller made by Sun Pharmaceutical Industries
MUMBAI, India — The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.
Sun announced the approval of tramadol hydrochloride extended-release tablets, a generic version of Valeant International’s Ultram ER. The drug is used to treat moderate to moderately severe chronic pain in adults who need constant treatment for an extended period of time.
Various versions of the drug have annual sales of $125 million, according to Sun.
FDA approves crush-resistant painkiller by Endo
CHADDS FORD, Pa. — The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.
Endo announced the FDA’s approval of a crush-resistant version of Opana ER (oxymorphone). Drug abusers often crush opioid pills in order to smoke, inhale or inject them. Endo developed the new formulation of the drug, scheduled for launch in 2012, using Grunenthal’s Intac technology. The new version will otherwise be identical to the old one.
"FDA’s approval of this new formulation of Opana ER is an important milestone for both the long-acting opioid category as well as Endo’s branded pharmaceutical portfolio," Endo EVP research and development and chief scientific officer Ivan Gergel said. "Patient safety is our top concern, and addressing appropriate use of opioids is a responsibility that we take very seriously."
Lilly names Harvard School of Public Health professor to board of directors
INDIANAPOLIS — Drug maker Eli Lilly has appointed Katherine Baicker to its board of directors, effective Dec. 12.
As a member of the board, Baicker — who is a professor of health economics in the department of health policy and management at the Harvard School of Public Health — will serve under interim election and will stand for election by Lilly shareholders at the company’s annual meeting in April 2012. As a member of the board, she also will serve on the public policy and compliance committee.
From 2005 to 2007, Baicker served as a Senate-confirmed member of the President’s Council of Economic Advisers, where she played a leading role in the development of health policy.