DETROIT, July 21 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) has started shipping bupropion hydrochloride extended release tablets. This product was recently approved by the US Food and Drug Administration (FDA) for Sun Pharma’s Abbreviated New Drug Application (ANDA). These bupropion hydrochloride extended release tablets, 100 mg, 150 mg, and 200 mg, are therapeutically equivalent to GlaxoSmithKline’s Wellbutrin SR® Extended Release tablets. These strengths of generic bupropion hydrochloride extended release tablets have annual sales of approximately $300 million in the US. Bupropion Hydrochloride (SR) Extended Release tablets are indicated for the treatment of major depressive disorder.
Wellbutrin SR® is a registered trademark of GlaxoSmithKline.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic pharmaceuticals to the nation’s largest wholesalers, distributors, drugstore chains and managed care providers.
Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Without limitation, the words “believe” or “expect” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in the Corporation’s filings with the Securities and Exchange Commission, including Part I, Item 1A of our most recent Form 10-K, and include but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or less expensive products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, material litigation from product recalls, the purported class action lawsuits alleging federal securities laws violations, delays in returning the Company’s products to market, including loss of market share, increased reserves against the FDA-seized inventory, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
