Impax Laboratories Inc announced that the US Food and Drug Administration (FDA) has granted final marketing approval to the company's Abbreviated New Drug Application (ANDA) for its generic version of Zyban, bupropion hydrochloride 150 mg Controlled Release Tablets.
GlaxoSmithKline markets Zyban for smoking cessation. According to NDCHealth, US sales of Zyban were approximately $63 million in the twelve months ended March 31, 2004.
"We are pleased to have received this, our seventh ANDA approval this year," said Larry Hsu, Impax Laboratories, Inc. president.
Impax currently has 15 applications pending at the FDA, including five tentatively approved, which address approximately $5.3 billion in US product sales for the twelve months ended March 31, 2004, based on NDCHealth data. Twelve of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.