to Market Generic Version of Zyloprim(R)
DETROIT, Aug. 31 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical
Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug
Administration (FDA) has granted final approval for the Company's Abbreviated
New Drug Application (ANDA) for Allopurinol Tablets USP, 100 mg and 300 mg
Allopurinol is indicated in the management of patients with signs and
symptoms of primary or secondary gout, the management of patients with
leukemia, lymphoma and malignancies who are receiving cancer therapy which
causes elevations of serum and urinary uric acid levels, the management of
patients with recurrent calcium oxalate calculi whose daily uric acid
excretion are elevated. Our generic Allopurinol is the bioequivalent to
Zyloprim(R), a registered trademark of Prometheus Laboratories, Inc. According
to IMS Data, for the twelve months ended June 2007, Allopurinol generic and
brand products (Zyloprim(R)) combined had annual sales of approximately $33
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased
to gain this approval from the FDA. Our focus continues to be working towards
expanding our product line effectively, including products that are already
available generically in the market that potentially can add measurable value.
We plan to market this product to the generic pharmaceutical market
immediately. This will bring our total product selection to 38 different
products represented by 78 various strengths."
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,
manufactures, markets and distributes generic and private-label
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. 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 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 cheaper
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, 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
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Daniel Movens or Mukul Rathi, +1-313-871-8400, or Aaron Miles, +1-313-556-4150,
all of Caraco Pharmaceutical Laboratories, Ltd.
-0- Aug/31/2007 15:41 GMT
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