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 for Healthcare Professionals - July 9, 2008

FDA Approves New Genetic Test for Patients with Breast Cancer (July 8)

The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.

FDA Approves First Generic Risperidone to Treat Psychiatric Conditions (June 30)

The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.

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

I added FDA drug search

It's so great that the FDA had a widget for their drug search. I added it to the right, right under Google search (or you can use the one on this page also).

It's easy to use. You just put in at least three sequential letters of the drug you want to find and it will show you all drugs that contain those three letters in a row. The only thing I don't like about the FDA site is it shows the drugs in all capitals, which is so annoying, but usually you can guess if it's capitalized or not (proper drug names capitalized, generics not capitalized) or you can do like I do, once I find it in the FDA site I Google it or look for it in my drug book. Handy Dandy.

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 new device approval

Talent thoracic stent graft (FDA original post here)

What is it? The Talent™ Thoracic Stent Graft System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Thoracic Stent Graft System is made of a fabric tube supported by a metal framework. Each endovascular graft is compressed into the end of a long, thin, tube-like device called a delivery catheter.

How does it work? The delivery catheter containing the endovascular graft is inserted into an artery in the groin through a small skin incision (cut). It is carefully guided within the artery through the abdomen into the chest (near the heart) to bridge the site of the aneurysm in the aorta. The endovascular graft is then deployed (released) and self-expands to the diameter of the aorta, to exclude (seal off) the aneurysm and reline the artery wall. The other section of the endovascular graft is deployed into the aorta in the same fashion.

When is it used? The Talent™ Thoracic Stent Graft System is used instead of more invasive open surgery in patients who have a descending thoracic aortic aneurysm.

What will it accomplish? The Talent™ Thoracic Stent Graft System should benefit patients with a descending thoracic aortic aneurysm by preventing further growth and rupture of the aneurysm.

When should it not be used? The Talent™ Thoracic Stent Graft should not be used in patients who have a condition that threatens to infect the graft or in patients with sensitivities or allergies to the device materials.

Additional information: The Summary of Safety and Effectiveness and labeling is available at: http://www.fda.gov/cdrh/pdf7/p070007.html

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


____________________________________________



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

Wait, don't use that nipple cream

The FDA issued a warning to women (and a few men I'm sure) Friday not to use Mommy's Bliss Nipple Cream.

The cream, promoted to nursing mothers to help soothe dry or cracked nipples, contains ingredients that may cause respiratory distress, vomiting and diarrhea in infants, the agency said.

The potentially hazardous ingredients in the cream are chlorphenesin and phenoxyethanol.

"FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," said Janet Woodcock, director of the Center for Drug Evaluation and Research. "Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants."

The company has stopped selling the cream. The FDA said consumers should stop using the cream and consult a doctor if they experience problems or believe that their infant may have experienced problems due to the product.

Mothers whose children may have suffered adverse effects because of this product should contact the FDA's MedWatch at 800-332-1088.

So be sure to read the label before rubbing that cream on your boobs.

________________________________________________

Buying fitness equipment should be the first priority before using such creams. If you have bursitis stick to a kettler otherwise you can go for treadmills as well as the bowflex.

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