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FDA Approvals - Chembio Receives CLIA Waiver for HIV 1/2 STAT-PAK(TM) (Business Wire


Chembio Receives CLIA Waiver for HIV 1/2 STAT-PAK(TM) (Business Wire via Yahoo! Finance)
MEDFORD, N.Y.----Chembio Diagnostics Inc. has received CLIA Waiver for one of its two FDA-approved rapid HIV tests, HIV 1/2 STAT-PAK. The CLIA waiver allows Chembio to market these HIV tests to a potential market of approximately 189,000 laboratory entities across the United States, including doctors' offices and clinics.

FDA Accepts as ``Complete Response'' Oscient Pharmaceuticals' Submission Following FACTIVE Approvable Letter for (Business Wire via Yahoo! Finance)
WALTHAM, Mass.----The U.S. Food and Drug Administration has accepted as complete Oscient Pharmaceuticals Corporation's response to the FACTIVE tablets approvable letter for the application seeking approval for the five-day treatment of community-acquired pneumonia of mild to moderate severity .

Barr's Subsidiary PLIVA Receives Approval for Pravastatin Tablets 10mg, 20mg, and 40mg and Tentative Approval for 80mg (FinanzNachrichten)
WOODCLIFF LAKE, N.J., Nov. 28 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, ( Nachrichten ) Inc. and its subsidiary PLIVA ( Nachrichten ) d.d. ( ZSE: PLVA-R-A) today announced that PLIVA has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Pravastatin Tablets 10mg, 20mg, and 40mg, the generic
 

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