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Home » Topics » Regulatory

Regulatory
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Indications for Glucovance broadened by FDA

Oct. 16, 2002

Avandamet approved for type 2 diabetes

Oct. 15, 2002

Kos files sNDA for Niaspan for reducing risk of stroke

Oct. 15, 2002

CIMA to develop fast-dissolve version of Allegra

Oct. 8, 2002

Roche seeks additional indication for Bondronat in E.U.

Oct. 7, 2002

FDA approves Augmentin XR for acute bacterial sinusitis and community-acquired pneumonia

Oct. 3, 2002

Marketing approval granted for first aldosterone blocker in high blood pressure

Oct. 1, 2002

Amgen files sBLA for Enbrel for improvement of physical function in RA

Oct. 1, 2002

Two rhBMP-2-based products now cleared for marketing

Sep. 26, 2002

First nucleotide analogue for HBV approved by FDA

Sep. 25, 2002
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