China Sky One Medical, Inc. Obtains SFDA Approval For Diclofenac Sodium Eye Drops

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 03 Jun 2009 - 1:00 PDT

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China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), announced that it obtained approval from the State Food and Drug Administration (SFDA) in China for the production of Diclofenac Sodium eye drops. The document number for the drug is 2009S02063.

Diclofenac Sodium eye drops are used to treat uveitis, keratitis and sclerotitis, conditions that affect the eye. They are able to inhibit new formations of unwanted vessels in the cornea and to reduce inflammation after various types of eye operations, such as laser treatment, cataract surgery and intraocular lens operations. Diclofenac Sodium eye drops also help cure seasonal conjunctivitis and allergic conjunctivitis. The generic drops are prescription medicines that are included in medical insurance catalogues in China and they will be available to consumers from China Sky One Medical in August 2009. Management expects that there will be a strong market for Diclofenac Sodium eye drops and that they will contribute $0.5 million to revenues in the first year of sales.

"China Sky One Medical has received production approvals for seven new drugs in 2009 and we greatly appreciate the strong efforts by our R&D and sales teams in bringing new drugs to market," said Mr. Yan-Qing Liu, Chairman and CEO of China Sky One Medical. "With the intelligence from our sales team, our R&D professionals can identify drugs that have strong market potential. We feel confidence that our robust product portfolio will create long term value for our shareholders."

About China Sky One Medical, Inc.

China Sky One Medical, Inc., a Nevada corporation, is a holding company. The Company engages in the manufacturing, marketing and distribution of pharmaceutical, medicinal and diagnostic products. Through its wholly-owned subsidiaries, Harbin Tian Di Ren Medical Science and Technology Company ("TDR"), Harbin First Bio-Engineering Company Limited ("First"), Heilongjiang Tianlong Pharmaceutical, Inc. ("Tianlong") and Peng Lai Jin Chuang Pharmaceutical Company ("Jin Chuang") the Company manufactures and distributes over-the-counter pharmaceutical products, which make up its major revenue source.

Safe Harbor Statement

Certain of the statements made in the press release constitute forward- looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by the use of forward- looking terminology such as "believe," "expect," "may," "will," "should," "project," "plan," "seek," "intend," or "anticipate" or the negative thereof or comparable terminology. Such statements typically involve risks and uncertainties and may include financial projections or information regarding the progress of new product development. Actual results could differ materially from the expectations reflected in such forward-looking statements as a result of a variety of factors, including the risks associated with the effect of changing economic conditions in The People's Republic of China, variations in cash flow, reliance on collaborative retail partners and on new product development, variations in new product development, risks associated with rapid technological change, and the potential of introduced or undetected flaws and defects in products, and other risk factors detailed in reports filed with the Securities and Exchange Commission from time to time.

Source: China Sky One Medical, Inc

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