R&D
Table 1: US therapeutic NME, new biological and vaccine approvals*
Product Generic name Company Indication Date
Arcalyst rilonacept Regeneron cryopyrin-associated periodic syndromes 27/2/08
Artiss f_i brin sealant (human) Baxter Healthcare skin graft attachment in burn patients 21/3/08
Bystolic nebivolol Mylan hypertension 17/12/07
(licensed to Forest Laboratories)
Cimzia certolizumab pegol UCB Crohn’s disease 22/4/08
Cinryze C1 esterase inhibitor (human) Lev Pharmaceuticals hereditary angioedema 10/10/08
(ViroPharma)
Cleviprex clevidipine The Medicines Company hypertension 1/8/08
Durezol dif_l uprednate Sirion Therapeutics ocular surgery inf_l ammation and pain 23/6/08
Entereg alvimopan Adolor/GlaxoSmithKline GI recovery following bowel surgery 20/5/08
Intelence etravirine Tibotec (Johnson & Johnson) HIV 18/1/08
Kuvan sapropterin Biomarin/Merck Serono phenylketonuria 13/12/07
Mircera methoxy polyethylene Roche anaemia associated with chronic 14/11/07
glycol-epoetin beta renal failure
Nplate romiplostim Amgen thrombocytopenia 22/8/08
Pristiq desvenlafaxine Wyeth major depressive disorder 29/2/08
Rapaf_l o silodosin Watson Pharmaceuticals benign prostatic hyperplasia 8/10/08
(licensed from Kissei
Pharmaceutical)
Recothrom thrombin topical Zymogenetics aid to hemostasis 17/1/08
(recombinant)
Relistor methylnaltrexone Progenics/Wyeth opioid-induced constipation 24/4/08
Toviaz fesoterodine Pf_i zer (licensed from overactive bladder 31/10/08
Schwarz Pharma/UCB)
Treanda bendamustine Cephalon chronic lymphocytic leukaemia, 20/3/08
(licensed from Astellas) non-Hodgkin’s lymphoma 31/10/08
Vimpat lacosamide Schwarz Biosciences (UCB) epileptic seizures 28/10/08
Voluven 6% hydroxyethyl starch 130/0.4 Fresenius Kabi hypovolemia 27/12/07
in 0.9% sodium chloride injection
Xenazine tetrabenazine Prestwick Pharmaceuticals (Biovail) Huntington’s disease chorea 15/8/08
Xyntha antihemophilic factor Wyeth Pharmaceuticals hemophilia A 21/2/08
(recombinant) plasma/albumin free
Vaccines
Kinrix GlaxoSmithKline diphtheria/tetanus/pertussis/polio 24/6/08
Pentacel Sanof_i Pasteur diphtheria/tetanus/pertussis/polio/ 20/6/08
Haemophilus inf_l uenzae type b
Rotarix GlaxoSmithKline rotavirus 3/4/08
* From November 2007 to October 31st, 2008
Source: US FDA
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