12 generic versions of Femara in market, FDA reports
SILVER SPRING, Md. — The Food and Drug Administration has approved a dozen new generic versions of a drug used to treat breast cancer, the agency said Monday.
The FDA said that on Friday it approved versions of Novartis’ drug Femara (letrozole) made by Teva Pharmaceuticals USA, Dr. Reddy’s Labs, Sun Pharmaceutical Industries, Impax Labs, Endo Pharmaceuticals, Roxane Labs, Accord Healthcare, Synthon Pharmaceuticals, Natco Pharma, Indicus Pharma, Fresenius Kabi Oncology and Kudco Ireland.
The agency originally approved Mylan’s version of the drug in December 2008, but Mylan didn’t launch until April 21 of this year.
Femara had sales of $682 million in 2010, according to IMS Health.
Alimta extends progression-free survival among patients in late-stage study
INDIANAPOLIS — Cancer patients taking a drug made by Eli Lilly extended the amount of time they survived without their disease worsening, according to results of a study announced Sunday.
Lilly said results of the phase-3 “PARAMOUNT” study of the injected drug Alimta (pemetrexed) extended progression-free survival in patients with nonsquamous nonsmall-cell lung cancer. The study focused on continuation maintenance when one of the same drugs used as a first-line treatment for cancer is continued as maintenance therapy in an effort to control the disease.
Results were presented Sunday at the 47th annual meeting of the American Society of Clinical Oncology in Chicago.
Study: Amylin’s metreleptin improves diabetes, lipid control among patients
SAN DIEGO — An investigational drug improved diabetes and lipid control in patients with partial lipodystrophy, according to a new study.
Amylin Pharmaceuticals announced Saturday results of a study of metreleptin, an analog of the human hormone leptin. Results of the study were presented at the 93rd annual meeting and expo of the Endocrine Society in Boston.
In the study, which the company is conducting under an investigational new drug treatment program authorized by the Food and Drug Administration, metreleptin is available to patients with rare forms of lipodystrophy who have one or more metabolic abnormalities, including diabetes and high levels of triglycerides in the bloodstream, also known as hypertriglyceridemia.
“We are committed to assisting patients who are living with lipodystrophy, a chronic and often debilitating disease that is not adequately managed by existing therapies,” Amylin SVP research and development Christian Weyer said. “Our expanded access program enables us to provide patients with metreleptin while we continue working with the FDA to make the medicine more broadly available to patients with this rare disorder.”