US Food and Drug Administration (FDA) has granted final approval to Impax Laboratories' Abbreviated New Drug Application (ANDA) for a generic version of OxyContin (Oxycodone Hydrochloride) Controlled Release 80mg Tablets.
Impax currently has 14 applications pending at the FDA, including four tentatively approved, which address approximately $4.3 billion in US branded product sales for the 12 months ended July 31, 2004. Nine of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.
"This is our tenth ANDA approval this year, which exceeds our full year total of nine in 2003," commented Barry R. Edwards, CEO of Impax. "We received tentative approval for the product late in 2003 and had anticipated final approval following the expiration of marketing exclusivity for the first ANDA filer. Operationally, we have been making preparations for a market launch, but because of outstanding issues, including pending patent infringement litigation by Purdue, a final decision on timing has not yet been made," he continued.
Purdue Pharma markets OxyContin for the management of moderate to severe pain. According to NDCHealth, US sales of OxyContin Controlled Release 80mg Tablets and its generic equivalent were $688 million for the 12 months ended July 31, 2004.
Impax Laboratories Inc is a technology-based specialty pharmaceutical company involved in the development of controlled-release and specialty generics in addition to the development of branded products.