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Thread: Able Laboratories, Inc. Receives FDA Approval for Indomethacin Extended-Release Capsules

  1. #1

    Able Laboratories, Inc. Receives FDA Approval for Indomethacin Extended-Release Capsules

    Able Laboratories, Inc. Receives FDA Approval for Indomethacin Extended-Release Capsules USP, 75 mg


    -- Generic version of Indocin(R) SR with estimated total market of

    36 million --

    SOUTH PLAINFIELD, N.J., Feb. 7 /PRNewswire-FirstCall/ -- ABLE LABORATORIES, INC. (OTC Bulletin Board: ABRX), today announced it has received Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Indomethacin Extended Release Capsules USP, 75 mg. The approval followed the FDA's Division of Bioequivalence determination that Able's Indomethacin Extended-Release Capsules USP, 75 mg. are bioequivalent and, therefore, therapeutically equivalent to the Indocin(R) SR Capsules of Eon Labs. The total generic and brand market for Able's newly approved drug, a capsule used to treat the rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, and acute painful shoulder, is estimated to be $36 million by IMS Data.

    Able Laboratories, Inc. (OTC Bulletin Board: ABRX) is a developer and manufacturer of generic pharmaceuticals. Since March 2001 Able has received 13 ANDA approvals and one approvable letter from the FDA. The Company has recently completed its transition to focus its activities primarily on generic drug development, manufacturing and sales.

    Certain information included in this news release as well as information included in oral statements or other written statements made or to be made by Able Laboratories, Inc., contain statements that are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements about the Company's capitalization, anticipated growth and future operations, current or expected market size for the products, the success of current or future product offerings, research and development efforts and the Company's ability to file for and obtain Food and Drug Administration (FDA) approvals for future products. There is no assurance that the Company will achieve the sales levels that will make its operations profitable or that ANDA filings and approvals will be completed and obtained as anticipated. The Company's forward-looking statements involve important risks and uncertainties that could significantly affect anticipated results in the future and, accordingly, actual results may differ materially from those expressed directly, indirectly or implied in any forward-looking statements made by or on behalf of the Company. For a description of additional risks, and uncertainties, please refer to the Company's filings with the Securities and Exchange Commission, including its registration statement on Form S-3, File No. 333-64734, its Annual Report on Form 10-KSB for the year ended December 31, 2000 and its quarterly report on Form 10-Q for the quarter ended September 30, 2001.

    Indocin SR is registered trademark of Eon Labs.

  2. #2

    Indocin

    The best and the biggest GI bleed I ever had was Indocin !! Never felt it coming...is sustained release supposed to prevent that?

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