Approved Drugs

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Abstract

Here we represent resources available, including FDA web sites, for information on the drug approval process and Critical Path Initiatives. We include information on the cost of clinical drug development, approved drugs since 1995, the largest pharmaceutical companies based on pharmaceutical sales, the top selling drugs in 2009, and the approved drugs in the first half of 2010.

Contents

11.1 Abbreviations 193

11.2 How Drugs Are Approved by the FDA 193

References 200

11.1 ABBREVIATIONS

CDER Center for Drug Evaluation and Research CPI Critical Path Initiative IND Investigational new drug NDA New drug application

11.2 HOW DRUGS ARE APPROVED BY THE FDA

The Center for Drug Evaluation and Research (CDER) regulates the process for testing drugs in humans. Before any drug is tested in clinical studies in the United States, the CDER must approve an investigational new drug (IND) application. For small molecules, a new drug application (NDA) must be approved after phase III

S.C. Khojasteh et al., Drug Metabolism and Pharmacokinetics 193 Quick Guide, DOI 10.1007/978-1-4419-5629-3_11, © Springer Science+Business Media, LLC 2011

clinical studies in order to market the drug (Tables 11.1-11.6). To learn more go to:

How Drugs are Developed and Approved (2010) FDA. http:// www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsare-DevelopedandApproved/default.htm. Accessed 3 September 2010

The FDA's Critical Path Initiative (CPI) is a strategy for expediting and improving the drug development process. To learn more go to:

Critical Path Initiative (2010) FDA. http://www.fda.gov/Science-Research/SpecialTopics/CriticalPathlnitiative/default.htm. Accessed 3 September 2010

Table 11.1. The cost of drug development (DiMasi et al. 2003)

Clinical phase

Mean (SD) in millions of dollars

Table 11.2. FDA-approved drugs since 1995 based on therapeutic area

Therapeutic area

1995-1999

2000-2004

2005-2009

Cardiology/vascular diseases

51

23

15

Dental/maxillofacial surgery

5

2

0

Dermatology/plastic surgery

31

15

8

Endocrinology

126

42

14

Gastroenterology

23

27

0

Hematology

15

12

17

Immunology/infectious diseases

64

40

38

Musculoskeletal

25

17

16

Nephrology/urology

25

22

12

Neurology

49

28

24

Obstetrics/gynecology

56

29

6

Oncology

57

33

26

Ophthalmology

17

9

10

Otolaryngology

7

3

5

Pediatrics/neonatology

38

19

24

Pharmacology/toxicology

11

3

3

Psychiatry/psychology

27

16

9

Pulmonary/respiratory diseases

54

21

8

Rheumatology

13

10

8

Trauma/emergency medicine

2

0

2

Total

696

371

245

FDA-Approved Drugs by Therapeutic Area (2010) Centerwatch. http://www. centerwatch.com/drug-information/fda-approvals/drug-areas.aspx. Accessed 3 September 2010

Table 11.3. The total revenue from the pharmaceutical, biological and generic drug markets and the top three therapeutic areas in 2009 in billions of dollars

Revenue Revenue from the top three therapeutic Drug market ($ billions) areas ($ billions)

Pharmaceutical 810 Central nervous system ! 125

Cardiovascular ! 110 Oncology ! 75

Biological 130 Monoclonal antibodies !40

Vaccines !25 TNF inhibitors ! 22

Generics 90

Top Ten/Twenty Best Selling Drugs 2009 (2009) Knol. http://knol.google. com/k/top-ten-twenty-best-selling-drugs-2009. Accessed 3 September 2010

Table 11.4. The top 12 largest pharmaceutical companies based on total revenue from pharmaceutical sales in 2009 (source annual reports)

Rank

Company

Country

Total revenue ($ billions)

1

Pfizer

USA

45.448

2

Sanofi-Aventis

France

36.131

3

GlaxoSmithKline

UK

35.127

4

Roche

Switzerland

34.522

5

AstraZeneca

UK

31.905

6

Novartis

Switzerland

28.538

7

Merck & Co.

USA

25.236

8

Johnson & Johnson

USA

22.520

9

Eli Lilly

USA

21.175

10

Abbott Laboratories

USA

16.486

11

Bristol-Myers Squibb

USA

15.272

12

Bayer HealthCare

Germany

12.375

Table 11.5. The top selling drugs in 2009

Generic name

2009 sales

(brand name)

Company

Indication

($ billions)

Atorvastatin

Pfizer, Astellas

High cholesterol

12.45

(Lipitor)

Clopidogrel

Bristol-Myers

Acute coronary

9.29

(Plavix)

Squibb, Sanofi Aventis

syndrome (reduction of thrombotic events)

Etanercept

Amgen, Pfizer,

Rheumatoid arthritis,

8.0

(Enbrel)

Takeda

juvenile rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis

Fluticasone,

GlaxoSmithKline

Asthma

7.76

Salmeterol

(Advair)

Infliximab

Johnson &

Rheumatoid arthritis,

6.91

(Remicade)

Johnson, Merck, Mitsubishi Tanabe

psoriasis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease

Valsartan

Novartis

Hypertension

6.01

(Diovan)

Bevacizumab

Roche

Colon cancer

5.92

(Avastin)

Rituximab

Roche

Non-Hodgkin's

5.80

(Rituxan)

lymphoma, rheumatoid arthritis

Aripiprazole

Otsuka, Bristol-

Schizophrenia

5.6

(Abilify)

Myers Squibb

Adalimumab

Abbott

Rheumatoid arthritis,

5.49

(Humira)

Laboratories

psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease

Trastuzumab

Roche

Breast Cancer

5.02

(Herceptin)

Esomeprazole

Astra-Zeneca

Ulcers

4.95

(Nexium)

Olanzapine

Eli Lilly

Schizophrenia

4.91

(Zyprexa)

Quetiapine

AstraZeneca

Schizophrenia

4.89

(Seroquel)

Astellas

Rosuvastatin

AstraZeneca,

High cholesterol

4.74

(Crestor)

Shionoggi

Continued

Table 11.5 Continued

Generic name

2009 sales

(brand name)

Company

Indication

($ billions)

Montelukast

Merck

Asthma

4.66

(Singulair)

Venlafaxine

Pfizer

Depression

4.3

(Effexor)

Insulin

Sanofi Aventis

Diabetes

4.22

glargine

(Lantus)

Enoxaparin

Sanofi Aventis

Deep vein thrombosis

4.17

(Lovenox)

Pioglitazone

Takeda

Diabetes

4.11

(Actos)

Table 11.6. Drugs approved in the first half of 2010 (January-August)

Generic name (brand name) Company

Tocilizumab (Actemra) Roche

Liraglutide (Victoza) Novo Nordisk

Dalfampridine (Ampyra) Acorda

Aztreonam (Cayston) Gilead Sciences

Meningitis vaccine (Menveo) Novartis

Trazodone hydrochloride (Oleptro) Pneumococcal 13-valent conjugate vaccine (Prevnar 13) Collagenase Clostridium histolyticum (Xiaflex) Velaglucerase alfa (Vpriv) Imiquimod (Zyclara) OnabotulinumtoxinA (Botox) Carglumic acid (Carbaglu) Hydromorphone hydrochloride (Exalgo extended release) Doxepin (Silenor) Rifaximin (Xifaxan) Miconazole (Oravig)

Pancrelipase (Pancreaze) Naproxen + esomeprazole (Vimovo)

Labopharm Wyeth

Auxilium Pharmaceuticals Shire Graceway Allergen Recordati Alza

Somaxon Pharma Salix Strativa Pharmaceuticals Johnson & Johnson AstraZeneca

Indication

Approval date

Rheumatoid arthritis

January 2010

Type 2 diabetes mellitus

January 2010

Improved walking in patients with

January 2010

multiple sclerosis

Cystic fibrosis

February 2010

Prevention of invasive meningococcal

February 2010

disease

Depression

February 2010

Prevention of invasive disease caused

February 2010

by Streptococcus pneumoniae

Dupuytrens contracture

February 2010

Type 1 Gaucher disease

March 2010

Actinic keratoses of the face and scalp

March 2010

Upper limb spasticity

March 2010

Hyperammonemia

March 2010

Pain

March 2010

Insomnia

March 2010

Hepatic encephalopathy

March 2010

Oropharyngeal candidiasis

April 2010

Exocrine pancreatic insufficiency Arthritis

April 2010 April 2010

Everolimus (Zortress)

Novartis

Prevention of kidney rejection after

May 2010

transplantation

Gatifloxacin ophthalmic solution

Allergen

Bacterial conjuctivitis

May 2010

(Zymaxid)

Ketorolac tromethamine (Sprix)

Roxro Pharma

Pain

May 2010

Estradiol valerate + dienogest (Natazia)

Bayer

Prevention of contraception

May 2010

Sipuleucel-T (Provenge)

Dendreon

Hormone refractory prostate cancer

May 2010

Mometasone furoate + formoterol fumarate

Merck

Asthma

June 2010

dihydrate (Dulera)

Denosumab (Prolia)

Amgen

Osteoporosis

June 2010

Cabazitaxel (Jevtana)

sanofi aventis

Prostrate cancer

June 2010

Olmesartan medoxomil + amlodipine +

Daiichi Sayko

Hypertension

July 2010

hydrochlorothiazide (Tribenzor)

Clindamycin phosphate + tretinoin (Veltin)

Stiefel

Acne vulgaris

July 2010

Ondansetron oral soluble film (Zuplenz)

Strativa

Chemotherapy and radiotherapy

July 2010

Pharmaceuticals

induced nausea and vomiting

IncobotulinumtoxinA (Xeomin)

Merz Pharmaceutical

Cervical dystonia and blepharospasm

July 2010

Glycopyrrolate (Cuvposa)

Shionogi

Chronic severe drooling in pediatrics

July 2010

Ulipristal acetate (Ella)

HRA Pharma

Prevention of contraception

August 2010

Lists of drugs approved in previous years can be found at:

FDA-Approved Drugs by Year (2010) Centerwatch. http://www.centei-watch.com/drug-information/fda-approvals/. Accessed 3 September 2010

References

DiMasi JA, Hansen RW, Grabowski HG (2003) The price of innovation: new estimates of drug development costs. J Health Econ 22:151-185

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