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Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal Year 2010
Date:1/28/2010

mp;A expenses, as a percentage of net sales, increased to 9% for the first nine months of Fiscal 2010, as compared to 4% for the corresponding period of Fiscal 2009. The higher percentage of SG&A is partly due to the lower sales in the current period versus the corresponding period last year.

Total R&D expenses incurred for the third quarter and first nine months of Fiscal 2010 were $2.8 million and $8.3 million respectively, as compared to $5.8 million and $16.9 million, respectively, during the corresponding periods of Fiscal 2009. The R&D expenses during the first nine months of Fiscal 2010 were lower compared to those during the corresponding period of Fiscal 2009 as we were reimbursed a certain amount relating to certain product litigation costs during the second quarter of Fiscal 2010, as part of a settlement agreement, as previously disclosed. Although R&D expenses have decreased in the current period due to the focus of the Company on remediating FDA concerns, they are likely to increase once the company refocuses on new product filings and approvals with the FDA.

Caraco filed two Abbreviated New Drug Applications ("ANDAs") relating to two products with the FDA during the first nine months of Fiscal 2010. The Company has not received FDA approval for any ANDAs during the first nine months of Fiscal 2010 and does not expect to receive any approvals for products out of its Michigan facilities until resolution of the FDA's concerns. The total number of ANDAs pending approval by the FDA as of December 31, 2009 was 31 (including four tentative approvals) relating to 27 products.  

As previously disclosed, the FDA has initiated certain actions and, as a consequence, production at the Company's Mich
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SOURCE Caraco Pharmaceutical Laboratories, Ltd.
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