BioPortfolio - Tercica
Increlex has received orphan drug exclusivity for its approved indication ... Recent Search Terms used to find this page: tercica lanreotide sales | Tercica
...
http://www.bioportfolio.com/biocorporate/10119-Tercica.html...
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FDA Approves New Drug to Treat Rare Disease, Acromegaly
... Food and Drug Administration today approved Somatuline Depot (lanreotide ... The Orphan Drug Act provides a seven-year period of exclusive marketing to ...
http://www.fda.gov/bbs/topics/news/2007/new01692.html...
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Draft Agenda
Request to establish a code for Lanreotide, trade name: Somatuline® Depot Injection. .... ISO-Vorin™ is an orphan drug. intended to rescue patients from
the ...
http://www.cms.hhs.gov/MedHCPCSGenInfo/Downloads/Drugs_summa...
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CDER New Molecular Entity (NME) Drug and New Biologic Approvals in ...
N022074, Somatuline Depot, lanreotide, Biomeasure, S,O, 30-Aug-07 ... O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law ...
http://www.fda.gov/Cder/rdmt/InternetNME07.htm...
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Tercica, Inc. and Ipsen: Somatuline(R) Depot Receives FDA ...
31 Aug 2007 ... The FDA has also designated Somatuline® Depot as an orphan drug for acromegaly. ... The active substance in Somatuline® Depot is lanreotide, ...
http://www.biospace.com/news_story.aspx?NewsEntityId=68283...
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PowerPoint Presentation
Lanreotide: 3 month treatment. •24% reduction in uterine volume at 3. months. • 17% reduction at 6 months; no rapid ... •Not marketed in US: orphan drug ...
http://orwh.od.nih.gov/fibroid_conference/stewart.pdf...
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BioPortfolio - Tercica - Profile
Increlex has received orphan. drug exclusivity for its approved indication of ... lanreotide, a somatostatin analogue which inhibits the excess secretion of
...
http://www.bioportfolio.com/biocorporate/10119-Tercica.pdf...
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Table 1 : 2007 FDA drug approvals: a year of flux : Nature Reviews ...
Lanreotide (Somatuline Depot), Biomeasure, Acromegaly ... O, FDA Orphan designation; P, FDA Priority Review; S, FDA Standard Review. ...
http://www.nature.com/nrd/journal/v7/n2/fig_tab/nrd2514_T1.h...
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List of Orphan Products Designa
230, Antiepilepsirine, Treatment of drug resistant generalized tonic-clonic ...... 1004, Lanreotide, Somatuline Depot, Long-term treatment of acromegalic
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http://www.fda.gov/orphan/designat/list.xls...
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Hematology-Oncology News - Index
New FDA Orphan Drugs: IPI-504, Pafuramidine, Preos The FDA has granted orphan drug ... and lanreotide acetate subcutaneous injection (Somatuline Depot). ...
http://www.medscape.com/index/list_1171_83...
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