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Watson Pharmaceuticals settles fraud allegations with Louisiana for $8.5 million

Watson Pharmaceuticals Inc. has agreed to pay Louisiana $8.5 million to settle allegations that it defrauded the state’s Medicaid program by artificially inflating its wholesale drug prices. The resolution came on Tuesday just before state attorneys were to give opening statements before a 12-person jury in Louisiana’s 19th Judicial District Court. Louisiana Attorney General Buddy Caldwell initiated the complaint against Watson Pharmaceuticals, alleging the company had defrauded taxpayers and the state’s Medicaid program by violating the Louisiana Unfair Trade Practices and Consumer Protection Act and Louisiana’s Medical Assistance Programs Integrity Law. “We are prepared to present these fraud cases to ... Read More

FDA pulls Teva’s generic Wellbutrin for working improperly

Teva Pharmaceuticals has stopped shipping its generic version of Wellbutrin XL 300 after a federal analysis found the antidepressant does not work in the same way the brand name drug does. Drug regulators discovered that Teva’s generic Wellbutrin XL 300, known by the name Budeprion, releases its key ingredient faster than the brand name Wellbutrin XL 300, which is made by GlaxoSmithKline. Generic drugs are ones that are comparable to brand-name drugs in dosage, strength, route of administration, quality and performance characteristics, and intended use. Generic drugs must contain the same active ingredients as the original formulation. Both Wellbutrin XL ... Read More

Generic Testim will carry same black box warning as brand name

Watson Laboratories Inc. has filed an application to market a generic version of Auxilium Pharmaceuticals’ testosterone gel, Testim. Last year, the testosterone-containing treatment generated revenues of $207.9 million for Auxillium. Testim is a prescription, topical gel that is applied to the shoulders and upper arms of men. It was approved by the Food and Drug Administration (FDA) in 2002 to treat low testosterone. In 2009, the FDA announced that it was ordering the manufacturers of Testim and another testosterone gel, AndroGel, to include a boxed warning on the Testim 1% and AndroGel 1% labels. The agency required this action after ... Read More

Generic Yaz will include same blood clot warnings

Watson Pharmaceuticals has launched Vestura, a generic version of Bayer’s blockbuster birth control pill Yaz. Like their brand-name counterpart, these pills will also carry a safety announcement on their packaging, warning users that studies suggest the drospirenone-containing pills may put users at greater risk for developing life threatening blood clots. Yaz, as well as the brands Yasmin, Beyaz, Safyral, and other generic varieties, combine the hormones drospirenone and ethinyl estradiol. Yaz and its generic versions had sales of about $510 million last year alone. Watson hopes to take a bite out of those profits. However, just as Watson was vying ... Read More