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Home » Topics » Regulatory

Regulatory
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Sepracor and 3M join forces to manufacture Xopenex HFA metered-dose inhaler

Jan. 10, 2002

EMEA recommends approval for desloratadine syrup and rapidly disintegrating tablets

Jan. 10, 2002

SkyePharma signs agreement to develop HFA-based Pulmicort systems

Jan. 9, 2002

Ortho-McNeil submits sNDA for Levaquin for nosocomial pneumonia

Jan. 8, 2002

FDA issues approvable letter for Trileptal as monotherapy for epilepsy in children

Jan. 2, 2002

FDA approves insulin analogue for pump therapy

Dec. 31, 2001

New option for early-stage prostate cancer receives FDA clearance

Dec. 27, 2001

Eisai to seek FDA approval for Aricept for vascular dementia

Dec. 24, 2001

Known antihypertensive drug introduced by Santen for glaucoma in Japan

Dec. 21, 2001

Nonapproval letter for GlaxoSmithKline's Augmentin XR extended-release tablets

Dec. 19, 2001
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