Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Acular(R) Opthalmic
Solution
DETROIT, Nov. 6 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories,
Ltd. (NYSE Amex: CPD) has launched ketorolac tromethamine ophthalmic solution,
0.5% following a final approval from the US Food and Drug Administration (FDA)
for Sun Pharma's Abbreviated New Drug Application (ANDA) for generic Acular®
opthalmic solution on the first day following patent expiration. This strength
of ketorolac is therapeutically equivalent to Acular® Ophthalmic Solution,
0.5%, from Allergan, Inc. Ketorolac tromethamine ophthalmic solution is
indicated for temporary relief of ocular itching due to seasonal allergic
conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated
for the treatment of postoperative inflammation in patients who have undergone
cataract extraction. Acular® opthalmic solution has annual sales of
approximately $40 million in the US.
Acular® is a registered trademark of Allergan, Inc.
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.
Jitendra Doshi, +1-313-556-4104, or Thomas Versosky, +1-313-556-4150, both of
Caraco Pharmaceutical
