FDA update, 08/27/2008

08/26/2008

Aloxi Capsules, (palonosetron hydrochloride) (prevention of nausea and vomiting from chemo)Helsinn Healthcare, SA, Approval

08/25/2008

Losartan Potassium Tablets (Cozaar), (angiotensin II receptor antagonist) Aurobindo Pharma, Ltd., Tentative Approval
Pamidronate Disodium Injection, (Aredia) (regulates blood calcium levels) Pliva-Lachema, AS, Approval

Holy smokes, two weeks worth the FDA updates

Yeah, I've been slacking - AGAIN - I feel bad, sorry. Here are bunches of FDA updates for you to add to your Drug Book if needed. Enjoy!!!

Oh, a word about these FDA updates. Sometimes the FDA approves different companies to put out the same medication. I just put the drugs that are approvals so sometimes they may already be drugs in the drug books, but I just put them anyway instead of checking to see if they're a repeat drug.

August 12, 2008
AK-Fluor (fluorescein sodium) (Fluorescein Injection) Injection, Akorn, Inc., Approval
Cefazolin Injection, (reduce the devt. of drug-resistant bacteria) Aurobindo Pharma, Ltd., Approval

August 11, 2008
cefepime injection, (antibiotic) Baxter Healthcare Corp., Approval
ramipril capsules, (ACE inhibitor) Cipla Ltd, Approval

August 8, 2008
alendronate sodium tablets (Fosamax) (osteoporosis), Apotex, Inc., Approval
cleviprex (clevidipine butyrate) (hypertension) injectable emulsion, The Medicines Co., Approval eplerenone tablets, (Inspra) (hypertension) Sandoz, Inc., Approval

August 7, 2008
adenosine injection, (Adenocard) (PSVT) Teva Parenteral Medicines, Approval
Ceftriaxone (ceftriaxone sodium) (antibiotic) intramuscular I.V. Injection, Aurobindo Pharma Ltd., Approval
divalproex sodium delayed-release tablets, (Depakote) (bipolar disorder) Wockhardt USA, Inc., Approval
dorzolamide hydrochloride ophthalmic solution, (Trusopt) (intraocular pressure) Apotex Corp., Tentative Approval
dorzolamide hydrochloride and timolol maleate ophthalmic solution, (Cosopt) (intraocular pressure) Apotex Corp., Tentative Approval
ranitidine (ranitidine hydrochloride) tablets, (acid reducer) Wockhardt USA, Inc., Approval

July 31, 2008
mycophenolate mofetil capsules, (CellCept) (prevention of organ rejection) Roxane Laboratories, Inc., Approval
Stavzor (valproic acid) Delayed-Release Capsules, Banner Pharmacaps, Inc., Approval
suiatriptan succinate Injection, Teva Parenteral Medicines, Tentative Approval

July 30, 2008
ketorolac tromethamine ophthalmic solution, (Acular) (NSAID)Alcon, Inc., Tentative Approval
Navstel (hypromellose, dextrose and glutathione) (intraocular injection) ophthalmic solution, Alcon, Inc., Approval
nisoldipine extended-release tablets, (hypertension) (Sular) Mylan Pharmaceuticals, Inc., Approval

July 29, 2008
pamidronate disodium injection, (Aredia) (osteoporosis, Paget's disease) PharmaForce, Inc., Approval

July 28, 2008
nicardipine hydrochloride injection, (Cardene) (calcium channel blocker) Teva Parenteral Medicines, Approval

July 25, 2008
Oxycodone Hydrochloride extended-release tablets, Mallinckrodt, Inc., Approval

July 24, 2008
Januvia (sitagliptin phosphate) Tablets, (type 2 diabetes) Merck & Co., Inc., Supplement

July 17, 2008
doxycycline oral suspension, (Vibramycin) (broad-spectrum antibiotics) IVAX Pharmaceuticals, Inc., Approval
indomethacin sodium injection, (Ductus arteriosus) Bedford Laboratories, Approval

July 16, 2008
meloxicam tablets, (Mobic) (NSAID) Beijing Double-Crane Pharmaceutical Co., Ltd., Supplement

FDA update, 7/8/2008

New and Generic Drug Approvals

Requip XL (ropinirole) (Parkinson's disease)Extended-Release Tablets, GlaxoSmithKline, Approval

Wow, I copied and pasted a whole bunch of drugs from the drug approvals and then realized that there was only one drug approval, the rest were labeling revisions. Sheesh, so there's only one sorta new drug today.

FDA Update, 7/5/2008

New and Generic Drug Approvals


amitriptyline hydrochloride tablets, (antidepressant)Caraco Pharmaceutical Laboratories, Ltd., Approval
Aptivus (tipranavir) Oral Solution, (treatment for AIDS and HIV)Boehringer Ingelheim Pharmaceuticals, Inc., Approval
azithromycin oral suspension, (treat bacterial infections)Teva Pharmaceuticals USA, Approval
betaxolol hydrochloride tablets, (beta blocker)KVK-Tech, Inc., Approval
dronabinol capsules, (Marinol) (1. Treatment of loss of appetite in AIDS patients. 2. Nausea and vomiting in cancer patients) Par Pharmaceutical, Inc., Approval
epoprostenol injection, (Flolan) (pulmonary hypertension) GeneraMedix, Inc., Approval
famotidine injection, (Pepcid) (heartburn) Akorn-Strides, LLC, Approval
PrandiMet (repaglinide and metformin hydrochloride) Tablets, (type 2 diabetes) Novo Nordisk, Inc., Approval

FDA Update, 7/1/2008

New and Generic Drug Approvals

Adenosine Injection, (antiarrhythmic agent)Bedford Laboratories, Tentative Approval
Anastrozole (anastrozone) Tablets (Arimidex), Sandoz, Inc., Tentative Approval
famotidine preservative-free (famotidine) Injection, Akorn-Strides, LLC, Approval
Granisetron Hydrochloride Injection (antiemetics for cancer treatment), Bedford Laboratories, Approval
lamotrigine Tablets, (Lamictal) (control seizures)Cobalt Laboratories, Inc., Tentative Approval
linezolid Tablets, (Zyvox) (treating serious bacterial infections) Mylan Pharmaceuticals, Inc., Tentative Approval
zidovudine syrup, (Retrovir) (HIV medication) Cipla, Ltd., Approval

FDA Update, 6/24/2008

New and Generic Drug Approvals

cetirizine hydrochloride syrup, (active ingredient in Zyrtec)Taro Pharmaceutical Industries, Ltd., Approval
Durezol (difluprednate) Ophthalmic Emulsion (first ophthalmic steroid indicated for inflammation and pain ), Sirion Therapeutics, Inc., Approval
ramipril Capsules, (Altace) (for hypertension)Dr. Reddy's Labs, Ltd., Approval
Ramipril Capsules, Apotex Corp., Approval
valganciclovir hydrochloride tablets, (Valcyte) (CMV retinitis) Ranbaxy, Inc., Tentative Approval
Zaleplon capsules, (sonata) (insomnia treatment)Cipla, Ltd., Approval

FDA Update, 6/20/2008

New and Generic Drug Approvals

buprenorphine hydrochloride tablets, (Subutex) (treatment of opiate dependence) Roxane Laboratories, Inc., Tentative Approval
cetirizine hydrochloride syrup, (Zyrtec) (allergies) Apotex Corp., Approval
cetirizine hydrochloride syrup, Perrigo Israel Pharmaceuticals, Ltd.., Approval
Claritin (loratadine) (allergies) Capsules, Schering-Plough HealthCare Products, Approval hydromorphone hydrochloride injection, (pain relief) (Dilaudid) Hospira, Inc., Approval
metoprolol tartrate tablets, (Lopressor)Ohm Laboratories, Inc., Approval
trandolapril tablets, (Mavik)(hypertension)Glenmark Generics Inc., USA, Approval
Trivaris (triamcinolone acetonide) (occular inflammation)Injectable Suspension, Allergan, Inc., Approval

June 18, 2008

Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules, Eli Lilly and Co., Approval
Requip XL (ropinirole) Extended-Release Tablets, (Parkinson's)GlaxoSmithKline, Approval
venlafaxine hydrochloride tablets, (Effexor) (depression)Caraco Pharmaceutical Laboratories, Ltd., Approval
venlafaxine hydrochloride tablets, Mylan Pharmaceuticals, Inc., Approval
venlafaxine hydrochloride tablets, Pliva Hrvatska, Approval
venlafaxine hydrochloride tablets, Sandoz, Inc., Approval
venlafaxine hydrochloride tablets, Zydus Pharmaceuticals USA, Inc., Approval

FDA Update, 6/16/2008

New and Generic Drug Approvals

butorphanol tartrate injection, (Stadol) Apotex Corp., Control Supplement
escitalopram oxalate tablets, (Lexapro) Lupin Pharmaceuticals, Inc., Tentative Approval
genotropin preservative free (somatropin [rDNA origin]) Injection, Pharmacia & Upjohn Co., New or Modified Indication
irbesartan and hydrochlorothiazide tablets, (Avalide) Mylan Pharmaceuticals, Inc., Tentative Approval

FDA drug approvals, 6/13/2008

New and Generic Drug Approvals

almotriptan malate tablets (Axert) (migraines), Teva Pharmaceuticals USA, Tentative Approval
ciclopirox gel (Loprox) (broad-spectrum antifungal medication), Nycomed US, Inc., Approval
prednisolone sodium phosphate oral solution (corticosteroid, used to treat severe allergies, arthritis, asthma, certain blood disorders, and skin conditions), Pharmaceutical Associates, Inc., Approval
ramipril capsules (Altace) (hypertension), Lupin Pharmaceuticals, Inc., Approval
valsartan tablets (Diovan) (hypertension), IVAX Pharmaceuticals, Inc., Tentative Approval

FDA drug approvals, 6/11/2008

New and Generic Drug Approvals

Zaleplon capsules, Roxane Laboratories, Inc., Approval
Zaleplon Capsules, Genpharm ULC, Approval
Zaleplon Capsules, Sandoz, Inc., Approval
Zaleplon Capsules, Upsher-Smith Laboratories, Inc., Approval
Zaleplon Capsules, Aurobindo Pharma USA, Inc., Approval
Zaleplon Capsules, Unichem Pharmaceuticals USA, Inc., Approval
Zaleplon Capsules, Teva Pharmaceuticals USA, Approval

FDA Update, 6/6/2008

New and Generic Drug Approvals

carbidopa and levodopa tablets, Apotex Corp., Approval
carbinoxamine maleate tablets, Boca Pharmacal, Inc., Approval
moexipril hydrochloride tablets, Apotex Corp., Approval
potassium chloride extended-release capsules, Andrx Pharmaceuticals, LLC, Approval
propranolol hydrochloride tablets, Ipca Laboratories, Ltd., Approval
Sprycel (dasatinib) Tablets, Bristol-Myers Squibb Co., Control Supplement
Stavudine oral solution, Aurobindo Pharma USA, Inc., Tentative Approval
Tradename To Be Determined (mesalamine) Delayed-Release Tablets, Procter & Gamble Pharmaceuticals, Approval

FDA Update, 6/4/2008

New and Generic Drug Approvals

acetaminophen and codeine phosphate tablets, Interpharm, Inc., Approval
alprazolam extended-release tablets, Interpharm, Inc., Approval
amantadine hydrochloride capsules, Banner Pharmacaps, Inc., Approval
cefpodoxime proxetil Tablets, Sandoz, Inc., Approval
clobetasol propionate lotion, Actavis Mid Atlantic, LLC, Tentative Approval
ethosuximide capsules, Covenant Pharma, Inc., Approval
hHydroxyzine hydrochloride tablets, Hetero Drugs, Ltd., Approval
midazolam hydrochloride injection, Wockhardt USA, Inc., Approval
mometasone furoate cream/ointment, Glenmark Generics, Inc., USA, Approval
ropinirole hydrochloride tablets, Wockhardt USA, Inc., Approval
temazepam capsules, Mutual Pharmaceutical Company, Inc., Tentative Approval
topiramate tablets, Lupin Pharmaceuticals, Inc., Tentative Approval

FDA Update, 6/3/2008

New and Generic Drug Approvals

hydrochlorothiazide Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
omeprazole delayed-release capsules, Andrx Pharmaceuticals, LLC, Approval
valsartan and hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval


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Patients of eczema still don’t have to worry as much as patients of asthma have to regarding the use of air purifiers and the regular use of dehumidifiers before and after using vacuum cleaners.

FDA Update, 5/30/2008

New and Generic Drug Approvals

Cetirizine hydrochloride syrup, (antihistamine) Teva Pharmaceuticals USA, Approval
Escitalopram oxalate tablets, (Lexapro) Apotex Corp., Tentative Approval
topiramate tablets, (Topamax)Cipla Ltd., Tentative Approval

FDA Update, 5/29/2008

New and Generic Drug Approvals

Benazepril Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval
Benazepril Hydrochloride Tablets, Zydus Pharmaceuticals USA, Inc., Approval
Lansoprazole Delayed-Release Capsules, TEVA Pharmaceuticals USA, Tentative Approval
Metformin Hydrochloride Tablets, Glenmark Pharmaceuticals Inc., USA, Approval
Omeprazole Delayed-Release Capsules, Dr. Reddy's Laboratories, Ltd., Tentative Approval
Rifampin Injection, Akorn-Strides, LLC, Approval

FDA Update, 5/24/2008

New and Generic Drug Approvals

cyclophosphamide injection, Baxter Healthcare Corp., Approval
Eloxatin (oxaliplatin) Injection, Sanofi-Aventis US, Inc., Efficacy Supplement with Clinical Data to Support
Fluoxetine (fluoxetine hydrochloride) Capsules, Teva Pharmaceuticals USA, Approval
Granisetron Hydrochloride Injection, Ebewe Pharmaceuticals, Inc., Tentative Approval
Milrinone Lactate in Dextrose 5% in Plastic Container Injection, Bedford Laboratories, Inc., Approval

FDA Update, 5/21/2008

New and Generic Drug Approvals

promethazine hydrochloride tablets, Impax Laboratories, Inc., Approval
Ropinirole Hydrochloride Tablets, Corepharma, LLC, Approval
venlafaxine hydrochloride Extended-Release Tablets, (Effexor XR) Osmotica Pharmaceutical Corp., Approval

FDA Update, 5/20/2008

New and Generic Drug Approvals

acetaminophen, caffeine and dihydrocodeine bitartrate Capsules, E5 Pharma, Inc., Manufacturing Revision
Butorphanol Tartrate Preservative Free Injection, Apotex Corp., Control Supplement
Emtriva (emtricitabine) Oral solution and capsules, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support - For HIV
Norvir (ritonavir) capsules and oral solution, Abbott Laboratories, Labeling Revision
Tekturna (aliskiren hemifumarate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support

FDA Update, 5/19/2008

New and Generic Drug Approvals

Atacand HCT (candesartan cilexetil and hydrochlorothiazide) Tablets, AstraZeneca LP, Formulation Revision
Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
Geodon (ziprasidone mesylate) Injection, Pfizer, Inc., Labeling Revision
ganisetron hydrochloride (Kytril) Injection, Wockhardt USA, Inc., Tentative Approval
hydrochlorothiazide Capsules, Apotex Corp., Approval
Invega (paliperidone) Extended-Release Tablets, Janssen LP, Labeling Revision
Keppra (levetiracetam) Injection, UCB, Inc., New or Modified Indication
Levitra (vardenafil hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
metoprolol succinate Extended-Release Tablets, KV Pharmaceutical Co., Approval
mitoxantrone hydrochloride (Novantrone) Injection, Dabur Oncology, Plc., Approval
Mycobutin (rifabutin) Capsules, Pharmacia and Upjohn Co., Labeling Revision
Nevirapine Tablets, Matrix Laboratories, Ltd., Tentative Approval
topiramate Capsules, Cobalt Laboratories, Inc., Tentative Approval

NEW HOPE FOR ALZHEIMER'S PATIENTS?

Alzheimer's patients may soon be getting a new drug to help combat their disease.

Dimebon from the US drugmaker Medivation Inc, has been shown in studies to help patients with mild to moderate forms of Alzheimer's improve memory, language, awareness of time and place, and a more complex process called "praxis", which means having an idea and then actually putting it into practice after one year on the active drug as compared to those taking a placebo.

Patients began showing improvement after 12 weeks, and were sustained after six months and a year. Also, at the six month point, the patients on the drug showed significantly better function on all five aspects of the disease than they did at the start of the trial.

The drugmaker is planning to start a second trial soon, after which it will apply for US and European marketing approval in 2010, said the company in a press statement.

The drug is also being evaluated as a treatment for Huntington's disease.