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FDA first-time generics approvals--2006.

FDA First-Time Generics Approvals--2006

GENERIC DRUG NAME         MANUFACTURER             BRAND NAME

JANUARY

Isradipine capsules       Abrika Pharmaceuticals   Dynacirc
USP, 2.5 mg and 5 mg                               capsules

Hydrocodone bitartrate    Mikart Inc.              Norco tablets
and acetaminophen
tablets USP, 5 mg/
300 mg

Clopidogrel bisulfate     Apotex Corp.             Plavix tablets
tablets, 75mg

Alprazolam extended-      Mylan Pharmaceuticals    Xanax XR
release tablets, 0.5 mg,  Inc.
1 mg, 2 mg and 3 mg

Testosterone gel 1%       Watson Laboratories      Androgel
                          Inc.

Nicotine polacrilex       Perrigo R&D Co.          Commit
lozenges, 2 mg and 4 mg

FEBRUARY

Cyclobenzaprine           Amide Pharmaceutical     Flexeril tablets
hydrochloride tablets     Inc.
USP, 5 mg

Cyclobenzaprine           Mylan Pharmaceuticals    Flexeril tablets
hydrochloride tablets     Inc.
USP, 5 mg (new strength)

Cyclobenzaprine           Sandoz Inc.              Flexeril tablets
hydrochloride tablets
USP, 5 mg (new strength)

Cyclobenzaprine           Watson Laboratories      Flexeril tablets
hydrochloride tablets     Inc.
USP, 5 mg and 7.5 mg
(new strengths)

Ranitidine injection      Ben Venue                Zantac injection
USP, 25 mg/ml, 6 ml       Laboratories Inc.
vials (new package size)

Ranitidine injection      Bedford Laboratories     Zantac injection
USP, 25 mg/ml, 40 ml                               (pharmacy bulk
vial (pharmacy bulk                                package)
package)

Fluticasone propionate    Roxane Laboratories      Flonase nasal
nasal spray, 0.05 mg      Inc.                     spray
(50 mcg)/spray

MARCH

Terconazole vaginal       Perrigo Co.              Terazol 3 vaginal
suppositories, 80 mg                               suppositories

Hydrocodone bitartrate    Mikart Inc.              Norco tablets, 7.5
and acetaminophen                                  mg/325 mg
tablets USP, 7.5 mg/
300 mg (new strength)

Glipizide                 Watson Laboratories      Glucotrol XL
extended-release          Inc.                     extended-release
tablets, 2.5 mg                                    tablets

Zidovudine capsules       Aurobindo Pharma Ltd.    Retrovir capsules
USP,100 mg

Pilocarpine               Impax Laboratories Inc.  Salagen tablets
hydrochloride tablets,
5 mg and 7.5mg

APRIL

Mitoxantrone injection    American Pharmaceutical  Novantrone
USP (concentrate),        Partners Inc.            injection
2 mg/ml, packaged in
20 mg/10 ml, 25 mg/12.5
ml and 30 mg/ 15 ml
multiple-dose vials

Mitoxantrone injection    Sicor Pharmaceuticals    Novantrone
USP (concentrate),        Inc.                     injection
2 mg/ml, packaged in
20 mg/10 ml, 25 mg/12.5
ml and 30 mg/15 ml
multiple-dose vials

Mitoxantrone injection    Mayne Pharma (USA) Inc.  Novantrone
USP (concentrate),                                 injection
2 mg/ml, packaged in
20 mg/10 ml, 25 mg/12.5
ml and 30 mg/15 ml
multiple-dose vials

Mitoxantrone injection    Bedford Laboratories     Novantrone
USP, (concentrate),                                injection
2 mg/ml, packaged in                               (concentrate)
20 mg/10 ml, 25 mg/12.5
ml and 30 mg/15 ml
multiple-dose vials

Benzphetamine HCL         Paddock Laboratories     Didrex tablets, 50
tablets, 50 mg            Inc.                     mg

Oxycodone and             Mikart Inc.              Percocet tablets,
acetaminophen tablets                              10 mg/650 mg
USP, 10 mg/650 mg

Pravastatin sodium        Teva Pharmaceuticals     Pravachol tablets
tablets, 10 mg, 20 mg     USA
and 40 mg

MAY

Colestipol hydrochloride  Impax Laboratories Inc.  Colestid
for oral suspension
USP, 5 g packet or
scoopful

Ketotifen fumarate        Apotex Inc.              Zaditor
ophthalmic solution,                               ophthalmic
0.025%                                             solution

Cefdinir capsules,        Lupin Ltd.               Omnicef
300 mg                                             capsules

Escitalopram oxalate      Ivax Pharmaceuticals     Lexapro tablets
tablets, 5 mg, 10 mg      Inc.
and 20 mg

Metronidazole topical     Altana Inc.              Metrolotion
lotion, 0.75%                                      topical lotion,
                                                   0.75%

Cefdinir for oral         Lupin Pharmaceuticals    Omnicef for oral
suspension, 125 mg/5 ml   Inc.                     suspension, 125
                                                   mg/5 ml

JUNE

Metronidazoletopical      Altana Inc.              Metrogel topical
gel 0.75%                                          gel

Potassium citrate         Corepharma LLC           Urocit-K
extended-release
tablets USP, 5 mEq and
10 mEq

Finasteride tablets       Ivax Pharmaceuticals     Proscar tablets
USP, 5 mg                 Inc.

Lamotrigine tablets       Teva Pharmaceuticals     Lamictal tablets
(chewable), 5 mg and      USA                      (chewable,
25 mg                                              dispersible)

Simvastatin tablets       Ranbaxy Inc.             Zocor tablets
USP, 80 mg

Simvastatin tablets       Ivax Pharmaceuticals     Zocor tablets
USP, 5 mg, 10 mg, 20 mg   Inc.
and 40 mg

Loratadine oral           Silarx Pharmaceuticals   Claritin hives
solution USP (O-T-C),     Inc.                     relief syrup
5 mg/5 ml

Tranylcypromine           Kali Laboratories Inc.   Parnate tablets,
sulfate tablets,                                   10 mg
10 mg (base)

Sertraline hydrochloride  Ivax Pharmaceuticals     Zoloft tablets
tablets, 25 mg (base),    Inc.
50 mg (base)
and 100 mg (base)

Sertraline                Roxane Laboratories      Zoloft oral
hydrochloride oral        Inc.                     concentrate
concentrate, 20 mg
(base)/ml

JULY

Azithromycin for oral     Pliva Inc.               Zithromax for oral
suspension USP, 100                                suspension
mg/5 ml and 200 mg/5 ml

Meloxicam tablets,        Breckenridge             Mobic tablets
7.5 mg and 15 mg          Pharmaceutical Inc.

Meloxicam tablets,        Corepharma LLC           Mobic tablets
7.5 mg and 15 mg

Meloxicam tablets,        Caraco Pharmaceutical    Mobic tablets
7.5 mg and 15 mg          Laboratories Ltd.

Meloxicam tablets,        Lupin Ltd.               Mobic tablets
7.5 mg and 15 mg

Meloxicam tablets,        Mylan Pharmaceuticals    Mobic tablets
7.5 mg and 15 mg          Inc.

Meloxicam tablets,        Watson Laboratories      Mobic tablets
7.5 mg and 15 mg          Inc.

Meloxicam tablets,        Zydus Pharmaceuticals    Mobic tablets
7.5 mg and 15 mg          USA Inc.

Meloxicam tablets,        Roxane Laboratories      Mobic tablets
7.5 mg and 15 mg          Inc.

Meloxicam tablets,        Teva Pharmaceuticals     Mobic tablets
7.5 mg and 15 mg          USA

Meloxicam tablets,        Glenmark                 Mobic tablets
7.5 mg and 15 mg          Pharmaceuticals Ltd.

Meloxicam tablets,        Par Pharmaceutical       Mobic tablets
7.5 mg and 15 mg

Meloxicam tablets,        Mutual Pharmaceutical    Mobic tablets
7.5 mg and 15 mg          Co.

Meloxicam tablets,        Actavis Totowa LLC       Mobic tablets
7.5 mg and 15 mg

Meloxicam tablets,        Genpharm Inc.            Mobic tablets
7.5 mg and 15 mg

Estradiol transdermal     Mylan Technologies Inc.  Climara
system, 0.0375 mg/24                               transdermal
hours and 0.06 mg/24                               system
hours (additional
strengths)

Finasteride tablets       Dr. Reddy's              Propecia tablets
USP, 1 mg                 Laboratories Ltd.

Metoprolol succinate      Sandoz Inc.              Toprol-XL
extended-release                                   extended release
tablets USP, 25 mg                                 tablets

AUGUST

Trimipramine maleate      Amide Pharmaceutical     Surmontil
capsules, 25 mg (base),   Inc.                     capsules
50 mg (base) and
100 mg (base)

Venlafaxine               Teva Pharmaceuticals     Effexor tablets
hydrochloride tablets     USA
25 mg (base), 37.5 mg
(base), 50 mg (base),
75 mg (base) and
100 mg (base)

Ciprofloxacin injection   Abraxis Pharmaceutical   Cipro injection
USP,10 mg/ml, packaged    Products
in 200 mg/20 ml and
400 mg/40 ml single-use
vials

Ciprofloxacin injection   Sicor Pharmaceuticals    Cipro injection
USP, 10 mg/ml, packaged   Inc.
in 200 mg/20 ml and
400 mg/40 mi single-use
vials

Ciprofloxacin injection   Hospira Inc.             Cipro injection
USP,10 mg/ml, packaged
in 200 mg/20 ml and
400 mg/40 ml single-use
vials

Ciprofloxacin injection   Bedford Laboratories     Cipro injection
USP, 10 mg/ml, packaged
in 200 mg/20 ml and
400 mg/40 ml single-dose
vials

Ciprofloxacin injection   Bedford Laboratories     Cipro injection
USP, 10 mg/ml, packaged
in 1,200 mg/120 ml
single-use vials,
pharmacy bulk package

Lamotriginetablets,       Teva Pharmaceuticals     Lamictal tablets
25 mg, 100 mg, 150 mg     USA
and 200 mg

SEPTEMBER

Levonorgestrel and        Watson Laboratories      Seasonale
ethinyl estradiol         Inc.                     tablets, 0.15 mg/
tablets USP, 0.15                                  0.03 mg
mg/0.03 mg

Loperamide                Ranbaxy Laboratories     Imodium
hydrochloride and         Ltd.                     advanced caplets
simethicone tablets                                (O-T-C)
(O-T-C), 2 mg/125 mg

Topirama tetablets, 25    Mylan Pharmaceuticals    Topamax tablets
mg, 100 mg and 200 mg     Inc.

Diltiazem hydrochloride   KV Pharmaceutical Co.    Tiazac extended-
extended-release                                   release capsules
capsules USP (once-a-day
dosage), 120 mg, 180 mg,
240 mg, 300 mg, 360 mg
and 420 mg

Prednicarbate cream,      Altana Inc.              Dermatop
0.1% (emollient) 0.1%                              emollient cream
                                                   0.1%

Caffeine citrate          Pharmaforce Inc.         Cafcit injection
injection USP, 20 mg/ml,
packaged in 60 mg/3 ml
single-dose vials

Caffeine citrate oral     Pharmaforce Inc.         Cafcit oral
solution USP, 20 mg/ml,                            solution
packaged in 60 mg/3 ml
vials

Famotidine tablets USP    Dr. Reddy's              Pepcid AC
(O-T-C), 20 mg            Laboratories Ltd.        tablets, 20 mg

Famotidine tablets USP    Perrigo R&D Co.          Pepcid AC
(O-T-C), 20 mg                                     tablets, 20 mg

Balanced salt solution    Akorn Inc.               BSS sterile
(sterile irrigation                                irrigating solution
solution)

OCTOBER

Colestipol hydrochloride  Impax Laboratories Inc.  Colestid tablets
tablets, 1 g 10/24/06

Metronidazole vaginal     QLT USA Inc.             Metrogel vaginal
gel 0.75%                                          gel

NOVEMBER

Oxybutynin chloride       Mylan Pharmaceuticals    Ditropan XL
extended-release          Inc.                     extended-release
tablets, 10 mg                                     tablets

Oxybutynin chloride       Impax Laboratories Inc.  Ditropan XL
extended-release                                   extended-release
tablets, 15 mg                                     tablets

Oxybutynin chloride       Mylan Pharmaceuticals    Ditropan XL
extended-release          Inc.                     extended-release
tablets, 5 mg                                      tablets

Sulfacetamide sodium      Altana Inc.              Klaron lotion
topical suspension
USP, 10%

Pravastatin sodium        Pilva Hrvatska D.O.O.    Pravachol tablets
tablets, 10mg, 20 mg,
30 mg and 40 mg

Ondansetron and           Sicor Pharmaceuticals    Zofran injection
dextrose injection,       Inc.                     premixed In
0.64 mg/ml, 50 ml                                  dextrose
flexible plastic
containers

Ondansetron injection     Teva Pharmaceuticals     Zofran injection
USP, 2 mg/ml, 40 ml       USA
vials

Ondansetron injection     Teva Pharmaceuticals     Zofran injection
USP, 2 mg/ml              USA
(preservative-free);
2 ml vials

Cefazolin for injection   Samson Medical           Kefzol for
USP (pharmacy bulk        Technologies LLC         injection
package), 100 g and
300 g

DECEMBER

Oxandrolone tablets       Upsher-Smith             Oxandrin tablets
USP, 2.5 mg               Laboratories Inc.

Oxandrolone tablets       Sandoz Inc.              Oxandrin tablets
USP, 2.5 mg and 10 mg

Paroxetine hydrochloride  Apotex Inc.              Paxil oral
oral suspension,                                   suspension
10 mg/5 ml

Trandolapril tablets,     Teva Pharmaceuticals     Mavik tablets
1 mg, 2 mg and 4 mg       USA

Bupropion hydrochloride   Anchen Pharmaceuticals   Wellbutrin XL
extended-release tablets  Inc.                     extended-release
USP, 150 mg and 300                                tablets
mg (once-a-day)

Albuterol sulfate and     Sandoz Inc.              Duoneb
ipratropium bromide                                inhalation
inhalation solution,                               solution
3 mg (0.083%) and 0.5
mg (0.017%),3 ml vials

Ondansetron oral          Roxane Laboratories      Zofran oral
solution USP, 4 mg/5 ml   Inc.                     solution

Ondansetron orally        Kali Laboratories Inc.   Zofran ODT
disintegrating tablets
USP, 16 mg and 24 mg

Ondansetron               Dr. Reddy's              Zofran tablets
hydrochloride tablets,    Laboratories Ltd.
16 mg (base)

Ondansetron               Dr. Reddy's              Zofran tablets
hydrochloride tablets,    Laboratories Ltd.
4 mg (base), 8 mg
(base) and 24 mg (base)

Ondansetron orally        Kali Laboratories Inc.   Zofran ODT
disintegrating tablets
USP, 4 mg and 8 mg

Methscopolamine bromide   Boca Pharmacal Inc.      Paminetablets
tablets USP, 2.5 mg                                and Pamine Forte
and 5 mg                                           tablets

FDA/Center for Drug Evaluation and Research.
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Title Annotation:Special Report
Publication:Chain Drug Review
Article Type:Statistical table
Geographic Code:1USA
Date:Feb 19, 2007
Words:1601
Previous Article:Industry has stake in trade policy.
Next Article:A growing number of patients are opting for generics alternative.
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