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Home » Topics » Regulatory

Regulatory
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E.U. approval obtained for once-weekly Actonel/Optinate for postmenopausal osteoporosis

Jan. 2, 2003

Once-daily Depakote ER approved for certain forms of epilepsy

Jan. 2, 2003

FDA approval for Xalatan as first-line therapy for elevated IOP

Jan. 2, 2003

Shire seeks approval of Adderall XR in adults

Dec. 23, 2002

Kytril available in oral solution for CINV and RINV

Dec. 23, 2002

Moxifloxacin NDA filed for bacterial conjunctivitis and ophthalmia neonatorum

Dec. 20, 2002

E.U. approval obtained for use of Enbrel in psoriatic arthritis

Dec. 20, 2002

Lantus: E.U. approval for flexible use, positive opinion for pediatric use

Dec. 19, 2002

Approvable letter for Advair Diskus

Dec. 19, 2002

Extended-release Cipro cleared for uncomplicated urinary tract infections

Dec. 18, 2002
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