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April 2008
April 1
Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy
April 4
SIGA Initiates Manufacture of ST-246 NDA Registration Batches
April 8
Collegium Pharmaceutical Announces FDA Filing for AllerNase, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis
April 9
Targanta Announces FDA Acceptance of Oritavancin New Drug Application
April 10
Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin
April 14
Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder
ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA
April 15
Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze for Hereditary Angioedema
Somaxon Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Silenor for the Treatment of Insomnia
April 22
Alpharma to Withdraw and Resubmit Its New Drug Application for Embeda
Sciele Pharma Announces FDA Acceptance of NDA for Addrenex Pharmaceuticals' CloniBID to Treat Hypertension
April 24
FDA Issues Not Approvable Letter for Icatibant in the Treatment of HAE
April 28
Schering-Plough/Merck Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast
April 29
MediQuest Therapeutics Submits New Drug Application to FDA for MQX-503 to treat Raynaud's Disease
Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant)
Acusphere Submits New Drug Application for FDA Approval of Imagify
April 30
Spherix D-tagatose to be Supplied by Inalco SpA
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