Calendar of July FDA Decisions
Posted on Saturday, July 12th, 2008 | In Biotech, Current Market NewsSciele Pharma (SCRX) – 7/15/08
LARx (head lice product) NDA
Different mode of action versus current neurotoxic lice killers
Theravance (THRX) – 7/21/08
Telavancin NDA
A good chance for a second approvable letter due to outstanding issues with trial conduct and recent approvable letters for other antibiotics
Warner Chilcott (WCRX) – 7/21/08
Topical alprostadil NDA
Amgen (AMGN) – 7/23/08
Nplate (romiplostim) BLA
Recommended by FDA Oncology Panel (with monitoring of patients)
Medicines Co. (MDCO) – 7/24/08
Angiomax sNDA
Vanda (VNDA)/Titan Pharma (TTP) – 7/27/08
Fanapta (iloperidone) NDA
Read my previous pan of both stocks
CV Therapeutics (CVTX) – 7/27/08
Ranexa (ranolazine) sNDA (3 label expansions)
first-line angina indication should boost sales + recent EU approval for second-line use in chest pain
Noven Pharma (NOVN) – 7/31/08
Stavzor (delayed-release valproic acid) NDA
Last 5 posts by Mike Havrilla
- RxNews Recap: 01-27-10 Repros Therapeutics rockets on news of FDA meeting. GenVec sinks on offering - January 27th, 2010
- Albertis $12.8B Bid to Lease PA Turnpike Expires with No Deal - October 1st, 2008
- Congress Working Overtime: $634B Spending Bill and Bailout Plan - September 27th, 2008
- Pfizer is a Big Pharma Buy - September 24th, 2008
- Bristol-Myers Ups Bid to $62 for ImClone - September 23rd, 2008
![]() About Mike Havrilla (http://mikehav.blogspot.com/)
The MikeHav Market Blog provides investors with a free source of stock profiles, tools, and commentaries focused on carbon credits, the healthcare sector, exchange-traded funds (ETFs), and innovative companies across all industries.
I am a pharmacist and index developer who has been investing since August 1997 and freelance writing for investors since April 2007. I am also an avid runner since 1992 and have completed 18 marathons (26.2 miles) with a personal best time of 2 hours, 54 minutes.
I can be contacted via email at mikehavrx[at]yahoo[dot]com.
MikeHav Market Blog: www.mikehav.blogspot.com
MikeHav Market Blog RSS Feed: http://feedproxy.google.com/mikehavblog
Investment Web Domain Names [PDF]: www.geocities.com/mikehavrx/websites.pdf
Global Carbon Trading Index [PDF]: www.geocities.com/mikehavrx/ctindex.pdf |




The MikeHav Market Blog provides investors with a free source of stock profiles, tools, and commentaries focused on 
