FDA grants tentative approval for Sandoz antibiotic
SILVER SPRING, Md. The Food and Drug Administration has given tentative approval to a generic antibiotic, according to agency records.
The FDA on Monday approved Sandoz’s levofloxacin oral tablets in 250-, 500- and 750-mg strengths.
The drug is a generic version of Johnson & Johnson’s Levaquin. Levaquin garnered sales of $1.65 billion in 2008, according to IMS Health data.
Warner Chilcott, Sanofi-Aventis clarify Actonel partnership
ARDEE, Ireland Warner Chilcott will take full control over the promotion, marketing and research-and-development decisions for an osteoporosis drug in the United States under an amendment to an agreement with French drug maker Sanofi-Aventis, Warner Chilcott announced Monday.
The earlier version of the agreement, for the drug Actonel (risendronate sodium), allowed Warner Chilcott to share the costs with Sanofi in the United States.
The agreement between the two companies expires at the end of 2014.
“The amendment to the collaboration agreement will enable Warner Chilcott to assume full control over the promotion and marketing of the Actonel brand in the United States,” Warner Chilcott president and CEO Roger Boissonneault said. “This will allow us to adjust our promotional plans in the U.S. as we prepare for the potential launch of the next-generation Actonel product.”
FDA seizes drugs from Beehive Botanicals
SILVER SPRING, Md. Federal government officials seized “dozens” of products from a company they said had been warned about misstating its medical benefits.
The Food and Drug Administration announced Monday that U.S. Marshals seized products including creams, capsules, tablets, gum, throat spray and shampoos from Haywood, Wis.-based Beehive Botanicals.
According to the FDA, the company misbranded the products by promoting them on its Web site as capable of preventing and curing diseases such as asthma, dermatitis, ulcers, cancer and others. The agency said that the claims meant the products were drugs and were thus subject to FDA regulation, but that Beehive had continued marketing them as medically beneficial despite not subjecting them to clinical trials.
“This seizure shows that the FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness,” FDA acting associate commissioner for regulatory affairs Michael Chappell said in a statement.
The FDA originally warned Beehive in March 2007 not to make drug claims on its Web site and products, and the company originally complied, but during inspections in September and October 2009, the agency said it found the company still was making inaccurate drug claims.