1. Top 25 Drugs in USA 2012 Data provided by IMS Health By prescription volume in the millions (i.e 10=10,000,000) For the full list please visit: http://www.pharmacytimes.com/publications/issue/201 3/July2013/Top-200-Drugs-of-2012

2. RankDrugManu.Other Names Used for RX Volume (in the millions) 1Hydrocodone/APAPActavisVicodin, Lorcet, Norco, Maxidone Pain managment56 2LevothyroxineMylanLevoxyl, Synthroid, Unithroid Hypothyroidism47 3Hydrocodone/APAPMallinkrodtVicodin, Lorcet, Norco, Maxidone Pain managment44 4LisinoprilLupinPrinvil, Zestril CHF, HTN42 5Hydrocodone/APAPQualitestSee 1,3 27

3. RankDrugManuOther Names Used forRx Volume (millions) 6SimvastatinLupinZocorSecondary Prevention of MI by reducing cholesterol 27 7AzithromycinTevaZithromax, Z- Pak, ZMax, TriPak Upper Respiratory Infections 26 8Proair HFATevaAlbuterol, Accuneb, Vospire ER, Proventil COPD, Asthma25 9CrestorAstraZenecaRosuvastatinSecondary Prevention of MI by reducing cholesterol 25 10LevothyroxineLannettSynthroid, levoxyl, unithroid Hypothyroidism25

4. RankDrugManuOther Names Used forRx Volume (in millions) 11SynthroidAbbvieSynthroid, levoxyl, unithroid Hypothyroidism23 12NexiumAstraZenecaEsomeprazoleGERD, acid reflux, and Zollinger Ellison 22 13AtorvastatinRanbaxyLipitorSecondary Prevention of MI by reducing cholesterol 22 14IbuprofenAmnealMotrin, Advil, Addaprin, Ultraprin Pain, Inflammation 21

5. RankDrugManu.Also Known As Used for RX Volume (in the millions) 15TrazodoneTevaOleptro, DesyrelDepression, Sleep aid, 21 16MetoprololMylanLopressor, Toprol MI (IV form); CHF, HTN 20 17AzithromycinGreenstoneZithromaxURI20 18WarfarinTaroCoumadin, Jantoven Anticoagulant for TE disorders 19 CymbaltaEli LillyDuloxetineAntidpressant, Neuropathic pain (unlabeled) 18 20Fluticasone Proprionate RoxaneFlonase (nasal), Flovent, Veramyst (Nasal) COPD, seasonal allergic rhinitis 18

6. RankDrugManuOther Names Used forRx Volume(in the millions) 21SingulairMerckMontelukastAsthmaN/G 22HydrochlorothazideQualitestHCTZ, Hydrodiuril, Microzide HTNN/G 23Ventolin HFAGlaxoSmith Kline Albuterol, Accuneb, Proventil asthmaN/G 24Advair DiskusGlaxoSmith Kline Fluticasone/Sal meterol COPD, asthmaN/G 25AmoxicillinSandozAmoxil, Moxatag URI, Otitis Media N/G

7. RankDrugUsed forDollar Sales (billions) 1Nexium ®(Esomeprzole)GERD5.9 2Abilify ® (Aripiprazole)Schizoprenia, Bipolar disorder 5.8 3Crestor ® (Rosuvastatin)Hypercholesterole mia 5 4Advair Diskus ®(fluticasone/Salmeterol) COPD4.8 5Cymbalta (Duloxetine)Depression, Neuropathic pain (unlabeled) 4.7 Top 25 Drugs in 2012 in the US by Dollar Sales

8. RankDrugUsed forDollar Sales (billions) 6Humira ® (adalimumab)RA, UC, Crohn’s Disease, AS 4.6 7Enbrel ®(etanercept)RA, UC, Crohn’s Disease, AS 4.3 8Remicade ® (Infliximab)RA, UC, Crohn’s Disease, AS 3.8 9Copaxone ® (glatiramer Acetate)Relapsing Remitting MS 3.5 10Neulasta ® (Pegfilgrastim)Prevention of infection in chemo receiving patients 3.4

9. RankDrugUsed forDollar Sales (billions) 11Singulair® (Montelukast)Asthma3.3 12Rituxan ®(Rituximab) CD20 ABChronic Lymphocytic leukemia, and in severe RA 3.1 13Plavix ® (clopidgrel)Stroke/MI prevention 2.9 14Atripla ®emtricitabine/tenofovir/efavirenz HIV infection2.8 15Spiriva® (Tiotropium)COPD, asthma2.8

10. RankDrugUsed forDollar Sales (billions) 16Oxycontin® (Oxycodone)Pain2.8 17Januvia ® (sitagliptin)Type 2 DM2.6 18Avastin ® (bevacizumab)Colorectal Cancer2.6 19Lantus ® (Insulin Glargine)Type 1 and Type 2 DM, basal insulin 2.3 20Truvada® (emtricitabine/tenofovir) HIV infection2.3

11. RankDrugUsed forDollar Sales (billions) 21Lantus Solostar ®(insulin glargine) (Pen filled dose form) Type 1 and Type 2 DM NG 22Epogen ® (erythropoetin)Anemia due to chemo, renal and other blood disorders NG 23Diovan ® (Valsartan)CHF, MI and HTNNG 24Lyrica® (Pregabalin)Neuropathic Pain relief NG 25Lipitor® (Atorvastatin)Cholesterol reduction NG

12. FDA Drug Approval Process In general, the process involves: Chemical drug development Animal testing Human testing Filing application to FDA New Drug Application (NDA) Biologics License Application (BLA) Approval by FDA Continuous Market Surveillance

13. Chemical development involves knowledge of the drug’s chemical properties and proposed pharmacology Animal testing involves testing the drug in animal primarily for excessive toxicity (rat and mice) IND (investigational new drug) application is filed to FDA for review If IND approved, clinical trials begin

14. Phase 1 trials 20-100 human volunteers Tests drug for safety and drug action General people are healthy volunteers Usually paid and/or reimbursements Phase 2 trials 100-1,000 people People with the disease state in question Determines minimal dose ranges Can be compensated Phase 3 trials Involves thousands of people with the disease state in question Dosage is pushed to determine max effectiveness Involves medical centers and major medical centers Involves IRB’s

15. After this the NDA (new drug application) is filed FDA review this application Thousands of pages long Requires scientist, clinician and statistician preparation and review Drug manufacturer submits proposed drug labeling If the application is approved, marketing of the drug is permitted in the US Phase IV trials Involves post marketing surveillance of drug in the population at large