Volume 39 - November 2007

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Latest FDA New Drug Approvals
The following drugs have recently been approved by the FDA.

Mircera (methoxy polyethylene glycol-epoetin beta) Injection
Date of Approval: November 14, 2007
Treatment for: Anemia Associated with Chronic Renal Failure
Mircera is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic renal failure.
Mircera Drug Information | Press Release

Combigan (brimonidine tartrate and timolol maleate) Ophthalmic Solution
Date of Approval: October 30, 2007
Treatment for: Intraocular Hypertension, Glaucoma
Combigan is an alpha adrenergic receptor agonist and beta adrenergic receptor inhibitor combination ophthalmic solution for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.
Combigan Drug Information | Press Release

Tasigna (nilotinib) Capsules
Date of Approval: October 29, 2007
Treatment for: Chronic Myelogenous Leukemia
Tasigna is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib.
Tasigna Drug Information | Press Release

Renvela (sevelamer carbonate) Tablets
Date of Approval: October 19, 2007
Treatment for: Hyperphosphatemia of Renal Failure
Renvela (sevelamer carbonate) is a calcium-free, metal-free, non-absorbed phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
Renvela Drug Information | Press Release

Voltaren Gel (diclofenac sodium) Topical Gel
Date of Approval: October 17, 2007
Treatment for: Osteoarthritis
Voltaren Gel (diclofenac sodium) is a topical gel non-steroidal anti-inflammatory (NSAID) medication indicated for the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.
Voltaren Gel Drug Information | Press Release

Ixempra (ixabepilone) Injection
Date of Approval: October 16, 2007
Treatment for: Breast Cancer
Ixempra (ixabepilone) is a semisynthetic analog of epothilone B indicated for the treatment of patients with metastatic or locally advanced breast cancer.
Ixempra Drug Information | Press Release

Doribax (doripenem) Injection
Date of Approval: October 12, 2007
Treatment for: Intraabdominal Infection, Urinary Tract Infection
Doribax is a penem antibacterial indicated for the treatment of complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis.
Doribax Drug Information | Press Release

More FDA Approvals


New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional diseases/conditions.

Abilify (aripiprazole)
New Indication Approved: November 16, 2007
Treatment for: Add-On Treatment of Major Depressive Disorder
Abilify is a dopamine partial agonist atypical antipsychotic drug. Abilify was first approved in November 2002 and is used for the treatment of schizophrenia, bipolar disorder and agitation associated with schizophrenia or bipolar mania. Abilify is now also indicated as an adjunctive, or add-on, treatment to antidepressant therapy (ADT) in adults with major depressive disorder (MDD).
Abilify Drug Information | Press Release

Nexavar (sorafenib) Tablets
New Indication Approved: November 16, 2007
Treatment for: Liver Cancer
Nexavar is an oral multi-kinase inhibitor anticancer drug. Nexavar was first approved in December 2005 for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer. Nexavar is now also approved for the treatment of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer.
Nexavar Drug Information | Press Release

Seroquel XR (quetiapine fumarate) Extended-Release Tablets
New Indication Approved: November 15, 2007
Treatment for: Maintenance Treatment of Schizophrenia
Seroquel XR is an atypical antipsychotic drug formulated for once-daily dosing. Seroquel XR was first approved in May 2007 for the acute treatment of schizophrenia in adult patients. Seroquel XR is now also approved for the maintenance treatment of schizophrenia in adult patients.
Seroquel XR Drug Information | Press Release

Protonix (pantoprazole sodium) for Delayed-Release Oral Suspension
New Dosage Form Approved: November 14, 2007
Treatment for: Gastroesophageal Reflux Disease
Protonix is a proton pump inhibitor drug which inhibits gastric acid secretion. Protonix Delayed-Release Oral Suspension is indicated for the treatment and maintenance of healing of erosive esophagitis with associated gastroesophageal reflux disease (GERD) symptoms and provides an alternative for adult patients who cannot swallow tablets. Protonix is also available as delayed-release tablets and I.V. injection.
Protonix Drug Information | Press Release

Crestor (rosuvastatin calcium) Tablets
New Indication Approved: November 8, 2007
Treatment for: Slowing the Progression of Atherosclerosis
Crestor is one of the HMG-CoA reductase inhibitor drugs. Crestor was first approved in August 2003 as an adjunct to diet for the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. Crestor is now also approved as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol.
Crestor Drug Information | Press Release


First Time Generic Approvals
First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.

Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg, 1 mg/0.03 mg, 1 mg/0.035 mg (21-Day and 28-Day)
Approved: October 26, 2007 Barr Laboratories, Inc.
Generic for: Estrostep-21 and Estrostep Fe Tablets

Rivastigmine Tartrate Capsules 1.5 mg (base), 3 mg (base), 4.5 mg (base), and 6 mg (base)
Approved: October 22, 2007 Sun Pharmaceutical Industries, Ltd.
Generic for: Exelon Capsules

Hydrocodone Bitartrate and Ibuprofen Tablets 2.5 mg/200 mg (New Strength)
Approved: October 19, 2007 Interpharm Inc.
Generic for: Vicoprofen Tablets

Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg
Approved: October 9, 2007 Roxane Laboratories, Inc.; Glenmark Pharmaceuticals, Ltd; Sun Pharmaceutical Industries Ltd.
Generic for: Trileptal Tablets

Risedronate Sodium Tablets 5 mg, 30 mg, and 35 mg
Approved: October 5, 2007 Teva Pharmaceuticals USA
Generic for: Actonel Tablets

Nifedipine Extended-Release Tablets USP, 90 mg
Approved: October 3, 2007 Osmotica Pharmaceutical Corp.
Generic for: Procardia XL Tablets


Latest FDA MedWatch Alerts
MedWatch alerts are concerning pharmaceuticals already released in the USA and are issued by the FDA.

Chantix (Varenicline)
November 20, 2007
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product.

Cefepime (marketed as Maxipime)
November 14, 2007
FDA issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime.

Avandia (rosiglitazone maleate) Tablets
November 14, 2007
FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks.

Erythropoiesis Stimulating Agents
November 8, 2007
FDA notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen, and Procrit pose to patients with cancer and patients with chronic kidney failure.

Trasylol (aprotinin injection)
November 5, 2007
FDA announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

NC Solution (antifungal product)
November 1, 2007
FDA notified healthcare professionals of the seizure of more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human or animal use, dietary supplements, and ingredients to make those products because some lacked FDA approval and all were maintained under grossly unsanitary conditions by General Therapeutics Corp., of St. Louis, Mo.

CellCept (mycophenolate mofetil)
October 29, 2007
Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney.

More FDA Medwatch Alerts


Other Drug News
The latest Pharmaceutical News & Articles brought to you by

92 Medicines and Vaccines now in Development for HIV/AIDS
November 20, 2007
Pharmaceutical researchers are testing 92 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA). December 1 marks the 20th anniversary of "World AIDS Day" -- a global awareness campaign that originated at the 1988 World Summit of Ministers of Health on Programmes for AIDS Prevention.

FDA Approves First Combination Therapy Avalide for Initial Use in Patients with Moderate to Severe Hypertension
November 19, 2007
Sanofi-aventis and Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for the antihypertensive agent Avalide for initial use in patients with hypertension who are likely to need multiple drugs to achieve their blood pressure goals.

FDA Approves the Allergy Treatment Zyrtec for Use Without a Prescription
November 16, 2007
McNeil Consumer Healthcare announced today that it received approval from the U.S. Food and Drug Administration (FDA) for the allergy treatment Zyrtec (cetirizine HCl) to be used without a prescription for adults and children. Zyrtec relieves symptoms due to perennial and seasonal allergic rhinitis, commonly referred to as indoor and outdoor upper respiratory allergies.

Number of Cases of Most Vaccine-Preventable Diseases in U.S. at All-Time Low
November 13, 2007
A comparison of illness and death rates for 13 vaccine-preventable diseases in the U.S., before and after use of the vaccine, indicates there have been significant decreases in the number of cases, hospitalizations and deaths for each of the diseases examined, according to a study in the November 14 issue of JAMA.

Results of a Survey of Parents' Perceptions of the Duration of Their Child's ADHD Medication Reported at Medical Meeting
November 9, 2007
Shire plc , the global specialty biopharmaceutical company, yesterday announced results of a national survey where 60 percent of 121 mothers reported their 6 to 12 year old child's once-daily Attention Deficit Hyperactivity Disorder (ADHD) medication stopped working before 6 p.m.

Merck Agreement to Resolve U.S. Vioxx Product Liability Lawsuits
November 9, 2007
Merck & Co., Inc. today announced that it has entered into an agreement with the law firms that comprise the executive committee of the Plaintiffs' Steering Committee of the federal multidistrict Vioxx litigation as well as representatives of plaintiffs' counsel in state coordinated proceedings to resolve state and federal myocardial infarction (MI) and ischemic stroke claims already filed against the Company in the United States.

More News Headlines


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