New Drug Applications Archive

New Drug Applications: February 2004

February 2 Mylan Laboratories and Watson Pharmaceuticals Announce Receipt of "Approvable" Letter for Emsam
February 2 Yamanouchi Pharma America Submits New Drug Application to the FDA for Conivaptan Hydrochloride to treat Hyponatremia
February 3 FDA Accepts Allos New Drug Application with Priority Review for RSR13 in Brain Metastases from Breast Cancer
February 4 FDA Approves Alimta for use with cisplatin, for the treatment of Malignant Pleural Mesothelioma
February 6 Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma
February 6 Aventis' Dermik Laboratories Announces FDA Acceptance of Filing For Sculptra to Treat Facial Lipoatrophy
February 6 Review of ISTA Pharmaceuticals' New Drug Application for Vitrase for Use as a Spreading Agent Extended 90 Days by FDA
February 17 La Jolla Pharmaceutical’s New Drug Application for Lupus Drug Candidate Riquent Accepted for Review by FDA
February 18 Biogen Idec and Elan Announce Intention to Submit for Approval for Multiple Sclerosis Based on One-Year Data
February 19 Access’ OraDisc A NDA Accepted For Filing
February 23 Eligard - Atrix Submits New Drug Application to FDA for First of Its Kind Six-Month Prostate Cancer Product
February 23 FDA Accepts Pharmion's New Drug Application for Filing and Grants Priority Review for Vidaza for the Treatment of Myelodysplastic Syndromes (MDS)
February 25 ZARS Inc. Announces FDA Actions on S-Caine Products
February 26 Biovail NDA For Ralivia ER -- Tramadol Extended Release Tablets -- Accepted for Review

New Drug Applications Archive

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