Latest FDA New and Generic Drug Approvals

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 30/July 1, 2004 [Includes Drug Label and Approval Letter]

  • Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, Barr Laboratories (Tentative Approval)
  • Promethazine Hydrochloride Tablets USP, Able Laboratories, Approval
  • Albuterol Sulfate Inhalation Solution, Nephron Pharmaceuticals, Approval
  • Blenoxane (bleomycin sulfate) for injection, Bristol-Myers Squibb, Labeling Revision
  • Cefuroxime for Injection USP and Dextrose Injection USP, B. Braun Medical Inc., Labeling Revision
  • Cefazolin for Injection USP and Dextrose Injection USP, B. Braun Medical Inc., Labeling Revision
  • Ditropan XL (oxybutynin chloride) extended release tablets, Johnson & Johnson, Efficacy Supplement
  • Florinef (fludrocortisone acetate tablets, King Pharmaceuticals, Inc., Labeling Revision
  • Lithium Carbonate Capsules, Able Laboratories, Inc. Approval
  • Loratadine Tablets USP, L. Perrigo Company, Approval
  • Mefoxin (cefoxitin) for Injection, Merck & Co., Inc., Labeling Revision
  • Oxycodone and Acetaminophen, Mallinckrodt, Inc., Approval
  • Propoxyphene Napsylate and Acetaminophen, Vintage Pharmaceuticals, Approval
  • Temodar (temozolomide) Capsules, Schering Corporation, Labeling Revision
  • Tequin (gatifloxacin) Tablets, Bristol-Myers Squibb, New or Modified Indication
  • Tequin (gatifloxacin) Injection and Tequin (gatifloxacin in 5% Dextrose) Injection, Bristol-Myers Squibb, New or Modified Indication
  • Terazol 7 (terconazole) Vaginal Cream, Johnson & Johnson, Labeling Revision
  • Terazol 3 (terconazole) Vaginal Suppositories, Johnson & Johnson, Labeling Revision
  • Terazol 3 (terconazole) Vaginal Cream, Johnson & Johnson, Labeling Revision

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 28, 2004 [Includes Drug Label and Approval Letter]

FDA revises the Effexor (venlafaxine HCl) and Effexor XR (venlafaxine HCl) labels to alert neuropsychiatric, obstetric and neonatology healthcare professionals to two important safety issues. See MedWatch Safety Information.

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 25, 2004 [Includes Drug Label and Approval Letter]

  • Cefotan (cefotetan) Injection, AstraZeneca
  • Keflex (cephalexin, USP) Pulvules, Eli Lilly and Company
  • Rogaine Men's Extra Strength (5% minoxidil) topical solution, Pfizer
  • Rogaine for Men Regular Strength and Rogaine for Women (2% minoxidil) topical solution, Pfizer
  • Vigamox (moxifloxacin HCl ophthalmic solution), Alcon Inc.

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 24, 2004 [Includes Drug Label and Approval Letter]

FDA approves first-time generic Levothyroxine Sodium for the treatment of hypothyroidism.
  • Amicar (aminocaproic acid) Tablets, Xanodyne Pharmacal, Inc.
  • Ammonium Lactate Lotion, Clay-Park Labs, Inc. (Generic Approval)
  • Hydrocodone Bitartrate and Acetaminophen, Mikart, Inc.
  • CAMPTOSAR Injection (irinotecan hydrochloride), Pfizer
  • Carbidopa and Levodopa Extended-release Tablets, KV Pharmaceutical (Generic Approval)
  • Cefzil (cefprozil monohydrate) for Oral Suspension and Tablets, Bristol-Meyers Squibb Company
  • Claforan (cefotaxime sodium) Injection, Aventis Pharmaceuticals Inc.
  • Clarithromycin Extended-release Tablets 500 mg, Andrx Pharmaceuticals (Generic Approval)
  • Efudex (fluorouracil) Topical Cream, Valeant Pharmaceuticals
  • Lidocaine Hydrochloride in 5% Dextrose Injection, B.Braun Medical
  • Loratadine Tablets, Perrigo Company (Generic Approval)
  • NITRO-DUR (nitroglycerin) Transdermal Infusion System, Schering Corporation
  • Rebetol and Rebetron Combination Therapy, Schering Corporation
  • Tamiflu (oseltamivir phosphate) dry powder for suspension, and capsules, Hoffmann-La Roche
  • ZOLADEX (goserelin acetate implant) Depot, AstraZeneca
  • Zyvox (linezolid) IV Injection, Oral Suspension, and Tablets, Pharmacia & Upjohn Company

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 23, 2004 [Includes Drug Label and Approval Letter]

FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION, and WARNINGS sections to encourage healthcare providers to engage in a thorough risk-benefit analysis, including consideration of the risk of hepatic failure associated with Serzone treatment, when deciding among alternative treatments available for depression. In addition, healthcare providers and consumers are cautioned about the need for close observation of patients being treated with antidepressants for clinical worsening of the symptoms of depression, for the emergence of suicidality, and for the emergence of a variety of other symptoms that may represent a worsening of the patient's condition. Serzone Safety Information.

  • Dimenhydrinate Injection, American Pharmaceutical Partners, Inc. (Generic Approval)
  • Econazole Nitrate, Clay-Park Labs, Inc. (Generic Approval)
  • Fluocinonide E Cream, Altana Inc. (Generic Approval)
  • Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals
  • Mylotarg (gemtuzumab ozogamicin) for Injection, Wyeth Pharmaceuticals
  • Levo-T (levothyroxine sodium tablets, Alara Pharmaceuticals
  • Levothyroxine Sodium Tablets, Mylan Pharmaceuticals, Inc.
  • Nicorette (nicotine polacrilex) gum, 2mg and 4 mg, GlaxoSmithKline

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 22, 2004 [Includes Drug Label and Approval Letter]

FDA and GlaxoSmithKline notify healthcare professionals of revisions to the labeling for the following drug products: Paxil (paroxetine hydrochloride) Tablets, Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets; Wellbutrin (bupropion hydrochloride) Tablets, Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets. These revisions alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. Paxil Safety Information. Wellbutrin Safety Information.

  • Cisplatin Injection, Bedford Laboratories
  • Codeprex (codeine polistirex and chlorpheniramine polistirex) Extended-Release, Celltech Pharmaceuticals (Approval)
  • Mucinex D (guaifenesin and pseudoephedrine HCl) Extended-release Tablets, Adams Respiratory (Approval)
  • Nesacaine and Nesacaine-MPF (chloroprocaine HCl) Injection, AstraZeneca
  • Fentanyl Transdermal System, Mylan, Tentative Approval

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 18, 2004 [Includes Drug Label and Approval Letter]

  • CombiPatch (estradiol/norethindrone acetate) transdermal system, Novartis Pharmaceuticals
  • Metformin Hydrochloride Extended-release Tablets, Teva Pharmaceuticals (Generic Approval)
  • Metformin Hydrochloride Extended-release Tablets, Ranbaxy Laboratories (Generic Approval)
  • Nicorette (nicotine polacrilex) gum, 2 mg and 4 mg, GlaxoSmithKline

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 17, 2004 [Includes Drug Label and Approval Letter]

    Fazaclo (clozapine, USP) Orally Disintegrating Tablets, Alamo Pharmaceuticals
  • Ibuprofen Tablets USP, LNK International
  • Imitrex (sumatriptan) tablets, GlaxoSmithKline
  • Prevacid (lansoprazole) for Delayed-Release Oral Suspension, and Delayed-Release Capsules, TAP Pharmaceutical
  • Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablet, TAP Pharmaceutical

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 16, 2004 [Includes Drug Label and Approval Letter]

  • Adenosine Injection, SICOR Pharmaceuticals (Generic Approval)
  • Adenosine Injection, Bedford Laboratories (Generic Approval)
  • Adenosine Injection, Baxter Healthcare (Generic Approval)
  • Carbidopa/Levodopa Extended-release Tablets, TorPharm, Inc. (Generic Approval)
  • Imodium A-D (loperamide HCL) Liquid, McNeil Consumer
  • Imodium (loperamide HCL/simethicone) Caplets, McNeil Consumer
  • Imodium Advanced (loperamide HCL/simethicone) Chewable Tablets and Caplets, McNeil Consumer
  • Metformin Hydrochloride Extended-release Tablets, Andrx Pharmaceuticals (Generic Approval)
  • Prograf (tacrolimus) Capsules and Injection, Fujisawa Healthcare

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 15, 2004 [Includes Drug Label and Approval Letter]

  • INOmax (nitric oxide) for inhalation, INO Therapeutics
  • Prevacid (lansoprazole) for Delayed-Release Oral Suspension and Delayed-Release Capsules, TAP Pharmaceutical
  • Prevacid SoluTab (lansoprazole), Delayed-Release Orally Disintegrating Tablet, TAP Pharmaceutical
  • Zegerid (omeprazole) Powder, Santarus, Inc. (Approval)
  • Zelnorm (tegaserod maleate) Tablets, Novartis Pharmaceuticals

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 14, 2004 [Includes Drug Label and Approval Letter]

  • Percodan / Percodan-Demi (Oxycodone and Aspirin) Tablets, Endo Pharmaceuticals

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 10, 2004 [Includes Drug Label and Approval Letter]

  • Butalbital, Acetaminophen, Caffeine and Codeine Phosphate, Anabolic Laboratories
  • ChloraPrep One -Step (2% chlorhexidine gluconate solution), Beckloff Associates
  • Doxazosin Mesylate Tablets, Clonmel Healthcare
  • Hipex (methenamine hippurate USP) Tablets, Aventis
  • Inderal (propranolol hydrochloride) LA Capsules, Wyeth
  • Inderide (propranolol hydrochloride and hydrochlorothiazide) Tablets, Ayerst Laboratories
  • Menostar (estradiol transdermal system), Berlex Laboratories
  • NutreStore (L-glutamine powder for oral solution), Nutritional Restart Pharmaceutical
  • Penicillin G Potassium Injection, Baxter Healthcare Corporation
  • Carvedilol Tablets, Teva Pharmaceuticals (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 9, 2004 [Includes Drug Label and Approval Letter]

FDA approves first-time generic Ciprofloxacin Tablets and Ophthalmic
Solution as an anti-infective.

  • Ciprofloxacin
    • Ophthalmic Solution, Bausch and Lomb, First Time Generic
    • Ophthalmic Solution, Novex Pharma, First Time Generic
    • Tablets, Barr, First Time Generic
    • Tablets, Cobalt Pharmaceuticals, First Time Generic
    • Tablets, Dr. Reddy's Laboratories, First Time Generic
    • Tablets, Hikma Pharmaceuticals, First Time Generic
    • Tablets, Ivax Pharmaceuticals, First Time Generic
    • Tablets, Martec Scientific, First Time Generic
    • Tablets, Mylan Pharmaceuticals, First Time Generic
    • Tablets, Ranbaxy Pharmaceuticals, First Time Generic
    • Tablets, Sandoz Scientific, First Time Generic

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 8, 2004 [Includes Drug Label and Approval Letter]

  • Rebetron Combination Therapy, Schering
  • Lexxel (enalapril maleate/felodipine ER) Tablets, AstraZeneca
  • Plendil (felodipine) Extended-Release Tablets, AstraZeneca

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 7, 2004 [Includes Drug Label and Approval Letter]

FDA approves Istalol (timolol maleate ophthalmic solution) 0.5%. This drug is indicated for the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

FDA approves Peginterferon alfa-2a co-packaged with ribavirin, USP. Peginterferon alfa-2a, alone or in combination with Copegus, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha.

  • Ancef (cefazolin) Injection, GlaxoSmithKline
  • Augmentin ES-600 (amoxicillin/clavulanate potassium) for Oral Suspension, GlaxoSmithKline
  • Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline
  • Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline
  • Ceftin (cefuroxime axetil), GlaxoSmithKline
    • for Oral Suspension
    • Tablets
  • Dextrose Sodium Chloride Injections, Baxter Healthcare
    • 5% in 0.9%
    • 5% in 0.45%
    • 5% in 0.33%
    • 5% in 0.2%
    • 10% in 0.9%
    • 2.5% in 0.45%
  • Flagyl I.V.RTU (metronidazole injection, Pfizer
  • Forteo [teriparatide (rDNA origin)] Injection, Eli Lilly
  • Humalog (insulin lispro [rDNA origin] injection), Eli Lilly
  • Istalol (timolol maleate ophthalmic solution), Senju Pharmaceutical
  • Lincocin (lincomycin hydrochloride), Pharmacia & Upjohn
    • Capsules
    • Injection
  • Merrem IV (meropenem for injection), AstraZeneca
  • Mefoxin Injection (cefoxitin sodium), Merck
  • Potassium Chloride, Baxter Healthcare
  • ProSom (estazolam tablets), Abbott Laboratories
  • Riomet (metformin HCl oral solution), Ranbaxy
  • Vantin (cefpodoxime proxetil), Pharmacia & Upjohn
    • Tablets
    • Oral Suspension
  • Viracept (nelfinavir mesylate), Pfizer
    • 250 mg tablets
    • oral powder
    • 625 mg tablets
  • Zerit (stavudine), Bristol-Myers Squibb
    • Capsules
    • Powder for Oral Solution
    • Zerit XR Extended-Release Capsules

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

June 1, 2004 [Includes Drug Label and Approval Letter]

FDA approves first-time generic Metronidazole Topical Cream, 0.75%
for the treatment of inflammatory papules and pustules of rosacea. The
innovator is MetroCream.

FDA approves first-time generic Itraconazole Capsules, 100 mg. as an
antifungal. The innovator is Sporanox.

  • Ammonium Lactate Lotion, Taro Pharmaceutical
  • Axert (almotriptan) tablets, Johnson & Johnson
  • Mobic (meloxicam) Oral Suspension, Boehringer Ingelheim
  • Remeron (mirtazapine), Organon Inc.
    • Immediate-Release
    • Orally Disintegrating Tablets
  • Thalitone (chlorthalidone) 15 mg Tablets, Monarch Pharmaceuticals

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

May 28, 2004 [Includes Drug Label and Approval Letter]

  • Arixtra (fondaparinux sodium) Injection, Fonda B.V.
  • Augmentin (amoxicillin/clavulanate potassium) Tablets, GlaxoSmithKline
  • Brevital (methohexital sodium) Injection, King Pharmaceuticals
  • Bupropion Hydrochloride Extended-release Tablets, Impax
  • Darvon Compound (propoxyphene hydrochloride, aspirin, and caffeine capsules), aaiPharma
  • Duramorph (morphine sulfate injection) and Infumorph (preservative-free morphine sulfate sterile solution), Baxter
  • Estraderm (estradiol transdermal system), Novartis
  • FreAmine III with Electrolytes, B.Braun Medical
  • Itraconazole Capsules, Eon Labs
  • Metronidazole Topical Cream, Altana
  • Midodrine Hydrochloride Tablets, Impax Laboratories
  • Minocin (minocycline for injection), Intravenous, Wyeth
  • Minocin (minocycline hydrochloride), Pellet-filled Capsules, Wyeth
  • Sanctura (trospium chloride) Tablets, Indevus Pharmaceuticals
  • Serzone (nefazodone hydrochloride) Tablets, Bristol-Myers Squibb
  • Talwin (pentazocine Lactate Injection, USP), Hospira
  • Vancocin (vancomycin hydrochloride) Pulvules, Eli Lilly
  • Wellbutrin Immediate Release Tablets, GlaxoSmithKline
  • Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline
  • Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline
  • Fenofibrate Tablets, Ranbaxy Laboratories (Tentative Approval)
  • Quinapril Hydrochloride Tablets, Mylan Pharmaceuticals (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

May 26, 2004 [Includes Drug Label and Approval Letter]

  • Amoxicillin and Clavulanate Potassium for Oral Suspension USP Powder Oral Suspension, Teva
  • Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablet, GlaxoSmithKline
  • Axid (nizatidine) Oral Solution, Reliant Pharmaceuticals
  • Brethine (Terbutaline Sulfate) Injection, American Pharmaceutical Partners
  • Clarithromycin Tablets Roxane Laboratories
  • BSS (balanced salt solution) Sterile Irrigating Solution, Alcon Laboratories
  • BSS Plus (sterile intraocular irrigating solution), Alcon Laboratories
  • Cantil (mepenzolate bromide USP) Tablets, Aventis
  • Gonal-f RFF Pen (follitropin alfa injection), Serono
  • Klor-Con (potassium chloride) Extended-release Tablets, Upsher-Smith Laboratories
  • Pediapred Oral Solution, Paddock Laboratories
  • Prozac (fluoxetine hydrochloride) Oral Solution, Eli Lilly
  • Velcade (bortezomib) for Injection, Millennium Pharmaceuticals
  • Xifaxan (rifaximin) Tablets, Salix Pharmaceuticals
  • Alendronate Sodium Tablets, Watson Laboratories (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

May 24, 2004 [Includes Drug Label and Approval Letter]

  • Dilt-CD (diltiazem hydrochloride USP) Extended-release Capsules, Torpharm
  • Lipitor (atorvastatin calcium) tablets, Pfizer
  • Morphine Sulfate Extended-release Tablets, KV Pharmaceutical
  • Velosulin BR (buffered regular human insulin [rDNA origin] injection), Novo Nordisk
  • Viramune (nevirapine), Boehringer Ingelheim Pharmaceuticals
    • Tablets
    • Suspension
  • Fluconazole Tablets, Dr. Reddy's Laboratories (Tentative Approval)
  • Terbinafine Hydrochloride Tablets, Andrx Pharmaceuticals (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

May 21, 2004 [Includes Drug Label and Approval Letter]

  • Avandamet, GlaxoSmithKline
  • Avandia, GlaxoSmithKline
  • Celexa (citalopram hydrobromide), Forest Laboratories
    • Tablets
    • Oral Solution
  • Cordarone (amiodarone HCl) Tablets, Wyeth
  • Invanz (ertapenem sodium), Merck
  • Lexapro (escitalopram oxalate), Forest Laboratories
    • Tablets
    • Solution
  • Paxil (paroxetine hydrochloride), Glaxo SmithKline
    • Immediate Release Tablets
    • Controlled Release Tablets
  • Primaxin IV  (imipenem and cilastatin), Merck
    • For Injection
    • Injectable
  • Zinacef (cefuroxime injection), Glaxo Group
  • Zinacef (cefuroxime for injection), Glaxo Group
  • Vidaza (azacitidine for injectable suspension), Pharmion Corp.

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

May 19, 2004 [Includes Drug Label and Approval Letter]

FDA approves Avelox (moxifloxacin hydrochloride) Tablets and I.V. to treat community-acquired pneumonia caused by multi-drug resistant Streptococcus pneumoniae.

FDA approves Taxotere (docetaxel) injection in combination with prednisone for the treatment of patients with advanced metastatic prostate cancer. This is the first drug approved for hormone refractory prostate cancer that has shown a survival benefit.

  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer
  • Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection), Bayer
  • DepoDur (morphine sulfate extended-release liposome injection), Skye Pharma
  • Fortaz (ceftazidime for injection), Glaxo Group
  • Fortaz (ceftazidime sodium injection), Glaxo Group
  • Gemzar (gemcitabine HCl) for Injection, Eli Lilly
  • Taxotere (docetaxel) for Injection Concentrate, Aventis
  • Zovirax (acyclovir sodium) for Injection, GlaxoSmithKline
  • Zovirax (acyclovir), GlaxoSmithKline
    • Capsules
    • Suspension
    • Tablets

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

May 18, 2004 [Includes Drug Label and Approval Letter]

  • Carbidopa-Levodopa Extended-release Tablets, Impax
  • Combivir (lamivudine/zidovudine) tablets, GlaxoSmithKline
  • Decadron (dexamethasone) Tablets, Merck
  • Flovent HFA (fluticasone propionate HFA) Inhalation Aerosol, GlaxoSmithKline
  • Levofloxacin Injection, Bedford Laboratories
  • Lovenox (fondaparinux sodium, injection), Aventis
  • Tindamax (tinidazole tablets), Presutti Laboratories

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

May 14, 2004 [Includes Drug Label and Approval Letter]

FDA approves four first-time generics for Ofloxacin Ophthalmic Solution for
the treatment of infections caused by susceptible strains of bacteria in
conjunctivitis and corneal ulcers.

FDA approves three first-time generics for fluticasone propionate cream, and
two for fluticasone propionate ointment.

  • Fluoxetine Oral Solution, Par Pharmaceutical
  • Fluticasone Propionate Ointment
    • Altana
    • Clay-Park Labs
  • Fluticasone Propionate Cream
    • Altana
    • Clay-Park Labs
    • Atrix Laboratories
  • Ofloxacin Ophthalmic Solution USP
    • Hi-Tech Pharmacal
    • Bausch & Lomb
    • Novex Pharma
    • Alcon Research

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

May 11, 2004 [Includes Drug Label and Approval Letter]

  • HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and bisacodyl tablets), Braintree Laboratories
  • Enjuvia (synthetic conjugated estrogens, B) tablets, Duramed Pharmaceuticals

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

May 3/4/5, 2004 [Includes Drug Label and Approval Letter]

  • Aricept (donepezil hydrochloride), Eisai, Inc.
  • Effexor XR (venlafaxine hydrochloride), Wyeth
  • Robaxin Injectable, Baxter Healthcare Corporation
  • Invanz, Merck
  • Neosporin, Monarch Pharmaceuticals
  • Neurontin (gabapentin) Tablets, Pfizer
  • Optivar, MedPointe Pharmaceuticals
  • Theophylline, Able Laboratories
  • Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride, Mylan Pharmaceuticals (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 29/30, 2004 [Includes Drug Label and Approval Letter]

  • Cetrotide, Serono
  • HepatAmine (amino acid injections), B.Braun Medical
  • Mucinex DM , Adams Respiratory Therapeutics
  • Zantac, GlaxoSmithKline
  • Fluconazole Injection, Baxter Healthcare (Tentative Approval)
  • Acetadote (acetylcysteine) Injection, Cumberland Pharmaceuticals
  • Efudex (fluorouracil) Topical Solution, ICN Pharmaceuticals
  • Fosamax (alendronate sodium) Tablets & Oral Solution, Merck
  • Ketoconazole Cream, Altana
  • Lac-Hydrin Lotion, Bristol-Myers Squibb
  • Methadone HCL Tablets, Mallinckrodt
  • Metolazone Tablets, Roxane Laboratories
  • Zithromax (azithromycin) Oral Suspension, Pfizer

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 27/28, 2004 [Includes Drug Label and Approval Letter]

  • Acetadote (acetylcysteine) Injection, Cumberland Pharmaceuticals
  • Fludarabine Phosphate Injection USP, Sicor Pharmaceuticals
  • Fortamet (metformin HCI ) Extended-Release Tablets, Andrx
  • Gabapentin Tablets, Ivax Pharmaceuticals (Split Approval/Tentative Approval)
  • Bextra (valdecoxib) Tablets, Pfizer
  • Hectorol (doxercalciferol) Capsules, Bone Care International
  • Humalog Mix 75/25, Eli Lilly
  • Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca
  • Nicorette (nicotine polacrilex) , GlaxoSmithKline
    • Gum 2mg
    • Gum 4mg
  • NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk
  • Propafenone Hydrochloride Tablets, Pliva
  • Proscar (finasteride) Tablets, Merck
  • Terbutaline Sulfate Injection, Bedford Laboratories
  • Theophylline Extended-Release Tablets, Able Laboratories
  • Topicort (desoximetasone) , Medicis Pharmaceutical
    • Gel
    • Ointment
    • Emollient Cream & LP Emollient Cream
  • Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline
  • Fluticasone Propionate Cream, Atrix Laboratories (Tentative Approval)
  • Levofloxacin Tablets, Teva Pharmaceuticals (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 23, 2004 [Includes Drug Label and Approval Letter]

  • Fosinopril Sodium Tablets, Ranbaxy
  • Fosinopril Sodium Tablets, Eon Labs
  • Humulin Mixture 70/30 Injection, Eli Lilly
  • M.V.I.-12 (multi-vitamin for infusion w/o vitamin K), aaiPharma

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 22, 2004 [Includes Drug Label and Approval Letter]

  • Advair Diskus (fluticasone propionate/salmeterol) Inhalation Powder, GlaxoSmithKline
  • Balziva-21 (norethindrone & ethinyl estradiol) Tablets, Barr Laboratories
  • Balziva-28 (norethindrone & ethinyl estradiol) Tablets, Barr Laboratories
  • Cladribine Injection, American Pharmaceutical Partners
  • Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly
  • Humalog Mix 75/25, Eli Lilly
  • Humulin N (human insulin [rDNA origin])., Eli Lilly
  • Mirtazapine Tablets, Caraco Pharmaceutical
  • Sodium Chloride Irrigation Solution, in Semi-Rigid Container, Abbott
  • Vfend (voriconazole) Tablets, Injection & Oral Suspension, Pfizer
  • Flumazenil Injection, Sicor Pharmaceuticals (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 21, 2004 [Includes Drug Label and Approval Letter]

  • Apokyn (apomorphine hydrochloride) Injection, Bertek Pharmaceuticals
  • Fragmin (dalteparin sodium injection), Pharmacia and Upjohn
  • Imagent (perflexane lipid microspheres), Imcor Pharmaceutical
  • Lovenox (enoxaparin sodium) Injection, Aventis
  • Zelnorm (tegaserod maleate) Tablets, Novartis

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 20, 2004 [Includes Drug Label and Approval Letter]

  • Micardis HCT (telmisartan/hydrochlorothiazide) Tablets, Boehringer Ingelheim
  • Premarin Intravenous (conjugated estrogens) Injection, Wyeth
  • Premarin (conjugated estrogens) Tablets, USP, Wyeth
  • Premarin (conjugated estrogens) Vaginal Cream, Wyeth
  • Prempro/Premphase (conjugated estrogens /medroxyprogeterone acetate) Tablets, Wyeth
  • Reglan (metoclopramide) Injection, Baxter Healthcare
  • Sandostatin LAR Depot (octreotide acetate) Injection, Novartis
  • Ultram (tramadol hydrochloride) & Ultracet (acetaminophen/tramadol hydrochloride) Tablets, Ortho-McNeil
  • Ofloxacin Ophthalmic Solution USP, Hi-Tech Pharmacal (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 16, 2004 [Includes Drug Label and Approval Letter]

  • Apidra (insulin glulisine [rDNA origin]) Injection, Aventis
  • Diazepam Injection, Parenta Pharmaceuticals
  • Dopram (doxapram hydrochloride) Injection, Baxter Healthcare
  • Fosamax (alendronate sodium) Tablets & Oral Solution, Merck
  • Intralipid I.V. Fat Emulsion, Fresenius Kabi
  • Mylotarg (gemtuzumab ozogamicin) Injection, Wyeth Pharmaceuticals
  • Thallous Chloride TI-201 Injection USP, Mallinckrodt
  • Zelnorm (tegaserod maleate) Tablets, Novartis

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 15, 2004 [Includes Drug Label and Approval Letter]

  • Detrol LA Extended Release Capsules, Pfizer
  • Trusopt (dorzolamide hydrochloride ophthalmic solution), Merck
  • Ziagen (abacavir sulfate) Tablets and Oral Solution, GlaxoSmithKline

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 14, 2004 [Includes Drug Label and Approval Letter]

  • Heparin Sodium in 5% Dextrose Injection, B. Braun Medical
  • Heparin Sodium in 0.9% Sodium Chloride Injection, B. Braun Medical
  • Lovenox (enoxaparin sodium) Injection, Aventis
  • Terconazole Vaginal Cream, Taro Pharmaceuticals
  • Tylenol Arthritis Pain (650 mg acetaminophen) extended release tablets, McNeil Consumer

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 12/13, 2004 [Includes Drug Label and Approval Letter]

  • Proscar (finasteride) Tablets, Merck
  • Abilify (aripiprazole) Tablets, Otsuka
  • Celexa (citalopram hydrobromide) Tablets & Oral Solution, Forest Laboratories
  • Effexor & Effexor XR (venlafaxine hydrochloride) Immediate & Extended Release Tablets & Capsules,Wyeth
  • Human Secretion Injection, ChiRhoClin
  • Lexapro (escitalopram oxalate) Tablets & Oral Solution, Forest Pharmaceuticals
  • Nasacort AQ (triamcinolone acetonide) Nasal Aerosol, Aventis
  • Paxil (paroxetine HCl) Imm ediate-Release & Controlled-Release Tablets, GlaxoSmithKline
  • Ritalin LA (methylphenidate hydrochloride) ER Capsules, Novartis
  • Sodium Chloride Irrigation Solution, Abbott Laboratories
  • Sotalol Hydrochloride Tablets (AF), Mutual Pharmaceutical
  • Sterile Water for Injection, USP, Abbott Laboratories
  • Vigamox (moxifloxacin hydrochloride) Ophthalmic Solution, Alcon
  • Loratadine Syrup, Novex Pharma (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm  

April 5/7, 2004 [Includes Drug Label and Approval Letter]

  • Ribasphere (Ribavirin) Capsules, Three River Pharmaceuticals
  • Ribavirin Capsules, Sandoz
  • Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets, Biovail
  • Pipracil (piperacillin sodium) Intravenous and Intramuscular, Wyeth
  • Protonix I. V. (pantoprazole sodium) Injection, Wyeth
  • Xanax XR (alprazolam) Extended-release Tablets & Tablets, Pfizer
  • Zantac (ranitidine hydrochloride) Efferdose, GlaxoSmithKline

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

April 1, 2004 [Includes Drug Label and Approval Letter]

  • Corlopam (fenoldopam mesylate) Injection, Abbott
  • Ketek (telithromycin) Tablets, Aventis
  • Zemplar (paricalcitol) Injection, Abbott
  • Risperidone Tablets, Mylan, (Tentative Approval)

Full details: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Drug approvals by year: www.fda.gov/cder/da/da.htm

Drug company news releases: Drugs.com Capsule News

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