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Home » Topics » Regulatory

Regulatory
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New formulation of Singulair available for young children with asthma

Sep. 25, 2003

Six-month priority review granted for Eloxatin sNDA

Sep. 22, 2003

Eisai submits E.U. Pariet application for on-demand therapy of symptomatic GERD

Sep. 22, 2003

FDA approves expanded Synagis labeling for children with congenital heart disease

Sep. 19, 2003

Cerezyme approved for type 3 Gaucher's disease in E.U.

Sep. 19, 2003

Valcyte approved for CMV prevention in transplant patients

Sep. 17, 2003

Efficacy of drug for dry mouth in preventing lung cancer claimed in recent patent

Sep. 17, 2003

Nexium intravenous formulation submitted to FDA

Sep. 17, 2003

First approval for Cubicin, Cubist's once-daily antibiotic for skin and skin structure infections

Sep. 16, 2003

Depakote ER approved for pediatric epilepsy

Sep. 16, 2003
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