Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release tablets, the generic equivalent to Biovail Laboratories International SRL's Cardizem
CD is widely prescribed for treatment of chronic chest pains, high blood pressure and prevention of heart attacks and strokes.
Glasser reported on 311 patients with chronic stable angina pectoris who participated in a 13-week double-blind placebo-controlled trial in which they took Cardizem
LA or placebo at night or in the morning.
The case, co-led by New York and Michigan, charged that for a year beginning in July 1998, Hoechst, a pharmaceutical company acquired by Aventis in 2000, paid Andrx just under $100 million not to market a generic version of Cardizem
CD is a once-daily medication for the treatment of high blood pressure and chest pain.
Aventis Pharmaceuticals, the maker of Cardizem
CD, and Andrx, a generic drug company, were accused of engaging in a price-fixing scheme that violated state and federal antitrust laws.
CD, which according to IMS data had 1998 United States sales of approximately $640 million, is expected to be the largest selling product of Aventis.
The case charged that beginning in July 1998, Hoechst, a pharmaceutical company acquired by Aventis in 2000, paid Andrx to not market a generic version of Cardizem
After purchasing the Cardizem
franchise from Aventis, Biovail went to work expanding Cardizem
's commercial appeal.
Treatment- related side effects were statistically similar between patients who received Cardizem
We alleged that the drug companies had overcharged consumers for Cardizem
CD by keeping cheaper generic versions of the drug off the market and the companies have agreed to make things right through a multimillion dollar settlement," said Attorney General Cox.
27 /PRNewswire/ -- Attorney General Mike Cox announced a proposed settlement today for $80 million involving the popular heart medication Cardizem
Andryx Corporation and affiliated entities for an alleged price-fixing scheme involving the popular heart medication Cardizem
based in New Jersey, and Andrx, based in Florida, charging the drug makers with entering into an illegal agreement not to market a much cheaper generic equivalent version of Cardizem
CD, used to treat high blood pressure and heart disease.
In the Analysis to Aid Public Comment issued by the FTC, the commission stated, "Based on the FTC's investigation, it does not appear that there was any delay in the entry into the market of a generic version of Cardizem
CD by Andrx or any other potential manufacturer, or that the conduct or agreement at issue delayed consumer access to a generic version of Cardizem