New Drug Applications Archive

New Drug Applications: 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
April 14	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
April 15	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
April 22	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
April 29	Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant)
April 29	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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