Ranbaxy approved to manufacture, market cardiovascular drug in Canada
GURGAON, India Canada’s drug regulation authority has given an Indian drug maker approval to manufacture a generic cardiovascular drug in the country.
Ranbaxy Labs announced Tuesday that Health Canada had granted it approval to manufacture and market Ran-Simvastatin (simvastatin) tablets in the 5 mg, 10 mg, 20 mg, 40 mg and 80 mg strengths.
Generic versions of simvastatin have sales of $153 million, according to IMS Health data.
Human Genome Sciences, GSK announce trial results for systemic lupus treatment
ROCKVILLE, Md. An investigational biotech drug for treating systemic lupus has done well in late-stage clinical trials so far, the two companies developing the drug announced Monday.
Human Genome Sciences and GlaxoSmithKline announced that the drug Benlysta (belimumab) met its primary efficacy goal in BLISS-52, the first of two phase 3 trials comparing it to standard methods of care and placebo in patients with systemic lupus erythematosus, also known as SLE. The companies said Benlysta was the first lupus drug to reach this advanced a stage in clinical development.
“The BLISS-52 results demonstrate that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus,” Human Genome Sciences president and CEO H. Thomas Watkins said in a statement. “Given the limited treatment options currently available, patients would benefit greatly from potential new treatments.”
The two companies entered an agreement to develop and commercialize Benlysta in August 2006.
FDA approves two additional strengths of generic schizophrenia drug
PITTSBURGH The Food and Drug Administration has approved two additional strengths of a generic version of a common schizophrenia drug.
Mylan announced Monday the approval of its haloperidol tablets in the 10 mg and 20 mg strengths. The company already markets the drug in strengths of 0.5 mg to 5 mg.
Haloperidol is used to control the symptoms of schizophrenia and Tourette syndrome and is a generic version of Johnson & Johnson’s Haldol, though J&J no longer manufactures Haldol in the tablet form. Haloperidol had sales of $21 million for the 12 months ending in March, according to IMS Health data.