16 New Medical Entities (NMEs) Approved by FDA in 2009

1. Savella (Milnacipran hydrochloride) http://www.savella.com/
   Cypress bioscience
   Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients.
2. Uloric (Febuxostat) http://www.uloric.com/
   Takeda pharmaceuticals
   Uloric is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. Uloric is not recommended for the treatment of asymptomatic hyperuricemia.
3. Afinitor (Everolimus) http://www.afinitor.com/
   Novartis
   Afinitor is a once-daily oral inhibitor of mTOR (mammalian target of rapamycin) for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.
4. Coartem (Artemether & lumefantrine) http://www.coartem.com/
   Novartis
   Coartem (artemether and lumefantrine) are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum.
5. Fanapt (Iloperidone) http://www.fanapt.com/
   Vanda pharmaceuticals
   Fanapt is an atypical antipsychotic agent indicated for the acute treatment of schizophrenia in adults.
6. Samsca (Tolvaptan) http://www.samsca.com/
   Otsuka America Pharmaceuticals
   Samsca is a selective vasopressin C2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium less than 125 per l or less marked hyponatremia that is symptomatic and has resisted correction with fluidrestriction], including patients with heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormone (SIADH).
7. Besivance (Besifloxacin hydrochloride) http://www.besivance.com/
   Bausch and Lomb
   Besivance (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis.
8. Multaq (Dronedarone hydrochloride) http://www.multaq.com/
   Sanofi Aventis US
   Multaq is an antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] less thn 40%), who are in sinus rhythm or who will be cardioverted.
9. Effient (Prasugrel hydrochloride) http://www.effient.com/
   Eli Lilly and Co.
   Effient is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows: patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI) or patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI.
10. Livalo (Pitavastatin calcium) http://www.livalo.com/
    Kowa
    Livalo is a HMG-CoA reductase inhibitor indicated for patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B),triglycerides (TG), and to increase high-density lipoprotein cholesterol.
11. Saphris (Asenapine) http://www.saphris.com/
    Organon USA Inc.
    Saphris is an atypical antipsychotic indicated for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar disorder in adults.
12. Sabril (Vigabatrin) http://24.249.12.134/
    Lundbeck Inc.
    Sabril is an antiepileptic drug (AED) indicated for refractory complex partial seizures in adults. It should be used as adjunctive therapy in patients who have responded inadequately to several alternative treatments.
13. Bepreve (Bepotastine besilate) http://www.bepreve.com/
    ISTA Pharmaceuticals
    Bepreve (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms allergic conjunctivitis.
14. Vibativ (Telavancin hydrochloride) http://www.vibativ.com/
    Theravance Inc.
    Vibativ is a lipoglycopeptide antibacterial indicated for the treatment of adult patients with complicated skin and skin structure infections (CSSSI) caused by susceptible gram-positive bacteria.
15. Votrient (Pazopanib hydrochloride) http://www.votrient.com/
    GlaxoSmithKline
    Votrient is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.
16. Istodax (Romidepsin) http://www.istodax.com/
    Gloucester Pharmaceuticals
    Istodax is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

- Vivek Sharma for Connotia (http://www.connotia.com/)