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Generic Percocet Approved by FDA
CORONA, Calif., Sept. 8 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Oxycodone and Acetaminophen (APAP) tablets in 7.5mg/325mg and 10mg/325mg strengths. Oxycodone/APAP is the generic equivalent to Endo Pharmaceuticals' Percocet® tablets and is indicated for the relief of moderate to moderately severe pain. For the 12-months ending June 2003, Percocet® 7.5mg/325mg and 10mg/325mg had sales of approximately $142 million.
The Company expects a full launch by late 2003 and timing is dependent on obtaining quota from the Drug Enforcement Administration, adequate supply of active ingredient, and build-up of launch quantities.
Source: Watson Pharmaceuticals, Inc.