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An Austin, Texas, dietary supplement wholesaler has pleaded guilty to four counts of conspiracy for introducing unapproved drugs into interstate commerce, counterfeiting human growth hormone, possessing controlled substances and distributing them, according to a joint announcement from the FDA and the U.S. Attorney for the Western District of Texas.
A federal judge has ruled that Apotex’s generic version of Abbott Laboratories’ treatment for epilepsy and mania associated with bipolar disorder infringes on the drugmaker’s patent.
Public Citizen has filed suit against the FDA, alleging the agency ignored the consumer group’s petition a year ago asking for a ban on the antidepressant drug nefazodone, which is marketed by Bristol-Myers Squibb (BMS) as Serzone.
Generic drugmakers planning to copy Dr. Reddy’s Laboratories’ strategy of marketing near-equivalent versions of brand drugs years before the basic patent expires will have to devise another plan after a recent appeals court ruling effectively ended Dr. Reddy’s challenge to Pfizer’s top-selling hypertension drug Norvasc, according to industry analysts.
Pfizer could set a new $1 billion record for drugmaker settlements of government sales and marketing investigations if new research from Merrill Lynch accurately reflects the government's approach to settling cases.
Pennsylvania has joined the growing list of states that are suing drugmakers for deceptive reporting of average wholesale prices (AWPs), inflating Medicaid and Medicare reimbursements and marketing the price spread to physicians to increase market share.
In a move that will likely delay the start of trials by at least seven months, Aventis has filed additional patent infringement claims against five generic firms challenging the drugmaker’s top-selling allergy products Allegra (fexofenadine HCl) and Allegra-D (fexofenadine HCl 60-mg/pseudoephedrine HCl 120-mg).
The Ohio attorney general has targeted Pfizer’s Pharmacia unit and several other drugmakers in a lawsuit that alleges the companies reported false average wholesale price (AWP) data to inflate Medicare and Medicaid reimbursements for prescription drugs.
Purdue Pharma is facing an antitrust lawsuit by two health insurers that allege the firm blocked generic competition on its pain treatment OxyContin (oxycodone).