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a=13
 Acular (ketorolac tromethamine ophthalmic solution) 0.5%
 Acular (ketorolac tromethamine ophthalmic solution) 0.5%
 Acuvail (ketorolac tromethamine)
 AK-Con-A (naphazoline ophthalmic)
 Akten (lidocaine hydrochloride)
 Alamast
 Alphagan (brimonidine)
 Alrex
 Astepro (azelastine hydrochloride nasal spray)
 AzaSite (azithromycin)
 Bepreve (bepotastine besilate ophthalmic solution)
 Besivance (besifloxacin ophthalmic suspension)
 Betaxon
 BSS Sterile Irrigating Solution
 Cosopt
 Durezol (difluprednate)
 Lotemax
 Lucentis (ranibizumab)
 Lumigan (bimatoprost ophthalmic solution)
 Macugen (pegaptanib)
 Ocuflox (ofloxacin opthalmic solution) 0.3%
 OcuHist
 Ozurdex (dexamethasone)
 Quixin (levofloxacin)
 Rescula (unoprostone isopropyl ophthalmic solution) 0.15%
 Restasis (cyclosporine ophthalmic emulsion)
 Salagen Tablets
 Travatan (travoprost ophthalmic solution)
 Valcyte (valganciclovir HCl)
 Viroptic
 Vistide (cidofovir)
 Visudyne (verteporfin for injection)
 Vitrasert Implant
 Vitravene Injection
 ZADITOR
 Zirgan (ganciclovir ophthalmic gel)
 Zymaxid (gatifloxacin ophthalmic solution)
FDA Approved Drugs for Ophthalmology
http://www.centerwatch.com/drug-information/fda-approvals/drug-areas.aspx?AreaID=13

Drugs Approved in 2010

Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial


conjunctivitis, Approved May 2010

Drugs Approved in 2009

Acuvail (ketorolac tromethamine); Allergan; For the treatment of pain and inflammation
following cataract surgery., Approved July 2009

Bepreve (bepotastine besilate ophthalmic solution); Ista Pharmaceuticals; For the treatment of
itching associated with allergic conjunctivitis, Approved September 2009

Besivance (besifloxacin ophthalmic suspension); Bausch & Lomb; For the treatment of bacterial
conjunctivitis, Approved June 2009

Ozurdex (dexamethasone); Allergan; For the treatment of macular edema following branch
retinal vein occlusion or central retinal vein occlusion, Approved June 2009

Zirgan (ganciclovir ophthalmic gel); Sirion Therapeutics; For the treatment of acute herpetic
keratitis, Approved September 2009

Drugs Approved in 2008

Akten (lidocaine hydrochloride); Akorn; For anesthesia during ophthalmologic procedures,


Approved October 2008

Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals; For the treatment of
seasonal and perennial allergic rhinitis, Approved October 2008

Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain
associated with ocular surgery, Approved June 2008

Drugs Approved in 2007

AzaSite (azithromycin); InSite Vision; For the treatment of bacterial conjunctivitis, Approved
April 2007

Drugs Approved in 2006

Lucentis (ranibizumab); Genentech; For the treatment of neovascular (wet) age related macular
degeneration, Approved June 2006
Drugs Approved in 2004

Macugen (pegaptanib); Pfizer / Eyetech Pharmaceuticals; For the treatment of wet age-related
macular degeneration., Approved December 2004

Drugs Approved in 2002

Restasis (cyclosporine ophthalmic emulsion); Allergan; For the treatment of low tear
production., December 2002

Drugs Approved in 2001

Lumigan (bimatoprost ophthalmic solution); Allergan; For the reduction of intraocular pressure
in patients with open-angle glaucoma or ocular hypertension, Approved March 2001

Travatan (travoprost ophthalmic solution); Alcon; For the reduction of elevated intraocular
pressure in patients with open-angle glaucoma or ocular hypertension, Approved March 2001

Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients
with AIDS, Approved March 2001

Drugs Approved in 2000

Betaxon; Alcon; For lowering IOP in patients with chronic open-angle glaucoma or ocular
hypertension, Approved February 2000

Quixin (levofloxacin); Santen; For treatment of bacterial conjunctivitis, Approved August 2000

Rescula (unoprostone isopropyl ophthalmic solution) 0.15%; Ciba Vision; For the treatment of
open-angle glaucoma or ocular hypertension, Approved August 2000

Visudyne (verteporfin for injection); QLT; For the treatment of wet age-related macular
degeneration (wet AMD), Approved April 2000

Drugs Approved in 1999

Alamast; Santen; pemirolast potassium ophthalmic solution, Approved September 1999

ZADITOR; Ciba Vision; Treatment for the prevention of itching of the eye, Approved July 1999

Drugs Approved in 1998

Alrex; Bausch & Lomb, Pharmos; Treatment for seasonal allergic conjunctivitis, Approved
March 1998

Cosopt; Merck; Treatment for glaucoma or ocular hypertension, Approved April 1998
Lotemax; Bausch & Lomb, Pharmos; Treatment for post-operative eye inflammation, Approved
March 1998

Salagen Tablets; MGI Pharma; Treatment for Sjogren's Syndrome, Approved February 1998

Viroptic; King Pharmaceuticals; Treatment for inflammation of the cornea in children due to
herpes simplex virus, Approved February 1998

Vitravene Injection; Isis Pharmaceuticals; Treatment for CMV in AIDS patients, Approved
August 1998

Drugs Approved in 1997

Acular (ketorolac tromethamine ophthalmic solution) 0.5%; Allergan; Treatment for


postoperative inflammation in patients who have undergone cataract extraction, Approved
January 1997

Acular (ketorolac tromethamine ophthalmic solution) 0.5%; Allergan; Treatment for post-
surgical inflammation following cataract extraction, Approved November 1997

BSS Sterile Irrigating Solution; Alcon; Treatment during ocular surgical procedures, Approved
December 1997

Drugs Approved in 1996

AK-Con-A (naphazoline ophthalmic); Akorn; Over-the-counter combination


vasoconstrictor/antihistamine product for opthalmic use, Approved January 1996

Alphagan (brimonidine); Allergan; Treatment for open-angle glaucoma and ocular hypertension,
Approved September 1996

Ocuflox (ofloxacin opthalmic solution) 0.3%; Allergan; Treatment for corneal ulcers, Approved
May 1996

OcuHist; Pfizer; Over-the-counter antihistamine eye drop, Approved January 1996

Vistide (cidofovir); Gilead; Treatment for cytomegalovirus (CMV) retinitis, Approved June 1996

Vitrasert Implant; Chiron; Drug delivery system for the treatment of cytomegalovirus, Approved
March 1996

Company Table
3M Drug Delivery Systems 112
AAIPharma Services 61
Akrimax Pharmaceuticals 111
Alliance Medical Products 75
Almac Pharma Services 90
Althea Technologies 98
American Stelmi Corporation 134
Anderson Packaging 99
Applied Laboratories 64
Argenta Limited 27
ARx, LLC 144
Avema Pharma Solutions 60
Avid Bioservices 109
Avrio Biopharmaceuticals 77
Baxter Healthcare Corp. 25
Bayer Healthcare 140
Ben Venue Laboratories 21
Bilcare 107
Bio Pharma Services Inc. 115
BioZone Laboratories 84
Boston Analytical, Inc. 95
Cangene bioPharma 114
Catalent Pharma Solutions 71,72
Celsis Analytical Services 62
Cerilliant 157
Chemic Laboratories, Inc. 100
Chemical Solutions Ltd. 43
Coating Place Inc. 31
Coldstream Laboratories 59
Compass Pharma 119
Confab Laboratories 131
Constantia Hueck Foils 58
Consumer Product Testing Co. 122
Contract Pharmacal Corp 9
CPL - Contract Pharmaceuticals
91
Ltd.
Cook Pharmica 87
CoreRx Inc. 139
Cortegra Group, Inc. 158
Crown Bioscience Inc 46
dermaCM 4
Diteba Research Laboratories 89
DJA Global Pharmaceuticals Inc. 23
DPT Laboratories 41, 42
Dr. Schleuniger Pharmatron 69
DSM Pharmaceutical Products 54
Duck Flats Pharma, LLC 55
EuTech Scientific Services, Inc. 147
Federal Equipment Company 32
Fleming Pharmaceuticals 13
Formatech, Inc. 94
Fresenius Kabi Product Partnering 17
G&W Laboratories, Inc. 74
Glatt Pharmaceutical Services 105
Global Clinical Connections 104
Gorbec Pharmaceutical Services 8
Grand River Aseptic Manufacturing 80
Halo Pharmaceutical 110
Harmony Labs 120
Haupt Pharma Inc. 15
HollisterStier Laboratories 101
Horizon Pharmaceuticals, Inc. 135
Hospira One 2 One 121
Huber-USA 125
Hyaluron Contract Mfg. - HCM 33
IGI Laboratories, Inc. 24
Impact Analytical 116
Importfab Inc 45
Integrated Analytical Labs 124
INTERPHEX 102
Intertek Expert Services 142
Intini Marketing, Inc. 149
Jeiven Pharmaceutical Consulting 39
JHP Pharmaceuticals 151
JP Laboratories Pvt Ltd 128
KMPT USA, Inc. 93
Lancaster Laboratories, Inc. 22
Laureate Pharma, Inc. 83
Lyne Laboratories 40
Lyophilization Services of New
78
England (LSNE)
Lyophilization Technology, Inc 129
Maxxam Analytics 159
Metrics, Inc. 10
METTLER TOLEDO 12
Micromeritics Pharmaceutical Services 57
Midas Pharmaceuticals 145
MIDI, Inc. 28
Mikart, Inc. 79
Myoderm 113
Neos Therapeutics 19
NextPharma Technologies 143
Norwich Pharmaceuticals, Inc. 51
Nosco, Inc. 47
OSO BioPharmaceuticals 154
Overlook Industries 18
Pace Analytical Life Sciences 108
Particle Sciences, Inc. 136
Particle Technology Labs 29
Patheon, Inc. 1
Pegasus Laboratories, Inc. 6
Penn Bottle & Supply Company 65
Penn Pharma Services 85
PennTech-Tofflon LLC 132
Perlen Packaging 3
Perritt Laboratories 146
Pharma Packaging Solutions 49
Pharma Tech Industries 11
Pharmaceutics International, Inc. - PII 68
Pharmatek Laboratories, Inc. 130
Pharmetics 20
Pillar5 Pharma Inc. 66
Piramal Healthcare 123
Platinum Press Inc. 73
PPD 133
Precision Stability Storage, LLC 76
PrePak Systems, Inc. 156
Primera Analytical Solutions Corp. 118
ProTecs 92
Puritan Products 38
Purple Diamond Testing Services 126
Q Laboratories, Inc. 26
QS Pharma LLC 5
Quality Chemical Laboratories 81
R.A.Chempharma Ltd. 35
Reed-Lane, Inc. 82
REIG JOFRE Group 16
Ropack Inc. 52
Rottendorf Pharma GMBH 48
Ruger Chemical Co., Inc. 141
Sannova Analytical Inc, 53
Seventh Wave Labs 153
SGS Life Science Services 70
Sharp Corporation 103
Sheffield Pharmaceuticals 117
Sigma-Tau PharmaSource 50
Sirius Analytical, Inc. 14
SL Pharma Labs, Inc. 37
Sterling Pharmaceutical Services 106
Suntec 7
Synomics Pharma 148
Tapemark Company 96
Tedor Pharma Inc. 152
Tekni-Plex 88
Testo, Inc. 2
TestPak, Inc 155
The Ritedose Corporation 36
Therapex, Div. of E-Z-EM Canada Inc. 34
Therapure Biopharma 67
Thermo Scientific 150
Tunnell Consulting 97
Uman Pharma Inc. 44
UPM Pharmaceuticals, Inc. 63
Velesco Pharmaceutical Services 137
Vindonwestech, Inc. 138
Walker Barrier Systems 127
Warnex Bioanalytical Services 56
WellSpring Pharmaceutical 30
West Pharmaceutical Services 160
Xerimis Inc. 86

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