FDA approves Warner Chilcott ulcerative colitis drug
DUBLIN — The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.
Warner Chilcott announced the approval of mesalamine in the 400-mg strength.
The company plans to market the drug under the brand name Delzicol and launch it in March.
Reports: Amgen plans six biosimilars
NEW YORK — Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.
Reuters reported that Amgen CEO Robert Bradway announced plans at a meeting with analysts and investors that the company would launch six biosimilars, including versions of Roche cancer drugs Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan (rituximab), and Eli Lilly’s cancer treatment Erbitux (cetuximab). It would also launch biosimilars of AbbVie’s autoimmune disorder treatments Humira (adalimumab) and Remicade (infliximab).
The six drugs represent combined sales of more than $40 billion, Reuters quoted an analyst as saying.
The Patient Protection and Affordable Care Act mandated a regulatory approval pathway for biosimilars, though the Food and Drug Administration is still working on creating regulations to govern them. Currently, a company seeking approval for a follow-on version of an off-patent biotech drug must undergo the FDA’s standard approval process for new drugs.
FDA gives tentative approval to Dr. Reddy’s hypertension drug
SILVER SPRING, Md. – The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.
The FDA granted tentative approval to Dr. Reddy’s Labs’ valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.
The drug is a generic version of Novartis’ Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.
Tentative approval means that a drug meets the FDA’s conditions for approval, but the agency can’t give it final approval due to patent or exclusivity issues.
In early January 2013, the U.S. District Court for the District of Columbia upheld an FDA decision protecting Ranbaxy Labs’ market exclusivity for its generic valsartan tablets.
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