Vol 41 - Jan 2008

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2007 - The Year in Drugs

The year 2007 saw a number of advances in drug research and development, with many new drugs approved over a wide range of medical conditions.


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

Recothrom (Thrombin, topical (Recombinant))
Date of Approval: January 17, 2008
Company: ZymoGenetics, Inc.
Treatment for: Hemostasis During Surgery
Recothrom is a recombinant form of human thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. Recothrom may be used in conjunction with an absorbable gelatin sponge, USP.
Recothrom Drug Information | Press Release

Alvesco (ciclesonide) Inhalation Aerosol
Date of Approval: January 10, 2008
Company: Nycomed
Treatment for: Asthma
Alvesco (ciclesonide) is an inhaled corticosteroid indicated for the maintenance treatment of asthma and prophylactic therapy in adult and adolescent patients aged 12 years and older.
Alvesco Drug Information | Press Release

Bystolic (nebivolol) Tablets
Date of Approval: December 17, 2007
Company: Forest Laboratories, Inc. and Mylan Inc
Treatment for: Hypertension
Bystolic is a once daily beta blocker that can be used alone or in combination with other antihypertensive agents. Bystolic is indicated for the treatment of hypertension.
Bystolic 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.

Tysabri (natalizumab) Injection
New Indication Approved: January 14, 2008
Treatment for: Crohn’s Disease
Tysabri is an integrin receptor antagonist first approved in 2004 for the treatment of relapsing forms of multiple sclerosis. Tysabri is now also approved for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies.
Tysabri Drug Information | Press Release

Sular (nisoldipine) Extended-Release Tablets
Formulation Revision: January 2, 2008
Treatment for: Hypertension
Sular is a calcium channel blocker indicated for the treatment of hypertension. The FDA has approved a new Sular formulation in four lower dosage strengths. The current 10 mg, 20 mg, 30 mg and 40 mg tablets will be replaced with lower, bioequivalent strengths (i.e., 8.5 mg, 17 mg, 25.5 mg and 34 mg).
Sular Drug Information | Press Release

Hepsera (adefovir dipivoxil) Tablets
Patient Population Altered: December 19, 2007
Treatment for: Chronic Hepatitis B in Patients 12 Years and Older
Hepsera is a nucleotide analogue first approved in 2002 for the treatment of chronic hepatitis B in adults. Hepsera is now also approved for the treatment of chronic hepatitis B in pediatric patients (ages 12 to 17 years).
Hepsera Drug Information

Vyvanse (lisdexamfetamine dimesylate) Capsules
Additional Dosage Strengths Approved: December 10, 2007
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)
Vyvanse is a prodrug of dextroamphetamine indicated for the treatment of attention deficit hyperactivity disorder (ADHD). Vyvanse is currently available in 30 mg, 50 mg and 70 mg dosage strengths and manufacturer Shire expects three additional dosage strengths of 20 mg, 40 mg and 60 mg will be available in retail pharmacies in the second quarter of 2008.
Vyvanse 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.

Fomepizole Injection 1 g/mL
Approved: December 14, 2007 Pharmaforce, Inc.
Generic for: Antizol Injection
Treatment for: Poisoning

Extended Phenytoin Sodium Capsules USP 30 mg
Approved: December 18, 2007 Wockhardt Limited
Generic for: Dilantin (Extended Phenytoin Sodium Capsules)
Treatment for: Seizures

Cetirizine Hydrochloride Tablets (OTC) 5 mg and 10 mg
Approved: December 27, 2007 Mylan Pharmaceuticals, Inc.; Caraco Pharmaceutical Laboratories, Ltd.; Par Pharmaceutical, Inc.; Ranbaxy Laboratories Limited; Sandoz Inc.
Generic for: Zyrtec Allergy Tablets/Zyrtec Hives Relief Tablets
Treatment for: Allergies

Diclofenac Sodium Ophthalmic Solution 0.1%
Approved: December 28, 2007 Bausch & Lomb Inc.; Nexus Pharmaceuticals, Inc.
Generic for: Voltaren Ophthalmic Solution
Treatment for: Ophthalmic Inflammation

Balsalazide Disodium Capsules 750 mg
Approved: December 28, 2007 Roxane Laboratories, Inc.
Generic for: Colazal Capsules
Treatment for: Ulcerative Colitis

Granisetron Hydrochloride Injection 0.1 mg (base)/1 mL; packaged in 0.1 mg (base)/ 1 mL Single-Use Vials
Approved: December 31, 2007 App Pharmaceuticals, LLC; Watson Laboratories, Inc.
Generic for: Kytril Injection
Treatment for: Nausea and Vomiting (associated with chemotherapy and anesthesia)

Granisetron Hydrochloride Injection (Preservative-Free) 1 mg (base)/mL; packaged in 1 mg (base)/1 mL Single-Dose Vials
Approved: December 31, 2007 Teva Parenteral Medicines, Inc.
Generic for: Kytril Injection
Treatment for: Nausea and Vomiting (associated with chemotherapy and anesthesia)

Granisetron Hydrochloride Injection 1 mg (base)/mL; packaged in 4 mg (base)/4 mL Multiple-Dose Vials
Approved: December 31, 2007 Baxter Healthcare Corporation
Generic for: Kytril Injection
Treatment for: Nausea and Vomiting (associated with chemotherapy and anesthesia)

Granisetron Hydrochloride Tablets 1 mg (base)
Approved: December 31, 2007 Barr Laboratories, Inc.; Teva Pharmaceuticals USA; Corepharma LLC; Roxane Laboratories, Inc.
Generic for: Kytril Tablets
Treatment for: Nausea and Vomiting (associated with chemotherapy and anesthesia)


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

Ortho Evra Contraceptive Transdermal Patch
January 19, 2008
FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.

Heparin Sodium Injection 1000 units/mL 10mL and 30 mL Vials
January 19, 2008
Baxter Healthcare and FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. Baxter is in the process of an in-depth investigation to determine the root cause of the reported reactions.

Heparin and Normal Saline Pre-Filled Syringe Flushes
January 18, 2008
AM2 PAT, Inc., notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Normal Saline pre-filled flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Sierratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Cough and Cold Medications in Children Less Than Two Years of Age
January 17, 2008
FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur.

Edetate Disodium (marketed as Endrate and generic products)
January 16, 2008
FDA notified healthcare professionals and patients about important safety information concerning Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA.

Compounded Menopause Hormone Therapy Drugs
January 10, 2008
FDA informed healthcare professionals and patients that the Agency sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency.

Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)
January 7, 2008
FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.

More FDA Medwatch Alerts


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

Welchol (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes
January 18, 2008
Daiichi Sankyo, Inc., announced today that the United States Food and Drug Administration (FDA) has approved Welchol (colesevelam HCl) to improve glycemic control (measured as hemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents. Welchol is now the first and only medication approved to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C).

Pfizer Statement on Chantix (varenicline) Labeling Update in the United States
January 18, 2008
Cigarette smoking is associated with significant morbidity and mortality. Smoking is the leading preventable cause of disease and premature death in the United States, with more than 438,000 U.S. deaths annually attributable to smoking. Patients who smoke cigarettes should be counseled to quit. Chantix was approved in May of 2006 in the U.S. as an aid to smoking cessation. Based upon post-marketing reports first reflected in a November 2007 labeling update, Pfizer today updated the Chantix label in the U.S. to include a warning that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.

HIV/AIDS Update - Reyataz (atazanavir) Package Insert Revisions
January 16, 2008
The Reyataz (atazanavir) package insert was revised to include information regarding the administration of atazanavir and/or atazanavir/ritonavir with food, proton pump inhibitors, H2 receptor antagonists, acetaminophen, and fluconazole. Additionally, dosing information in patients with renal impairment was included.

Supreme Court Declines to Consider Whether Those Near Death Have Right of Access to Experimental Drugs (Abigail Alliance v. Eschenbach)
January 14, 2008
The U.S. Supreme Court issued an order today declining to take up the issue of whether terminally ill patients have a "fundamental right" – protected by the U.S. Constitution – to access to experimental drugs that have not yet been fully approved by the Food and Drug Administration (FDA). The denial was a setback for the Washington Legal Foundation (WLF), which filed the review petition on behalf of itself and the Abigail Alliance for Better Access to Developmental Drugs, a patients-rights group.

Removing Thimerosal from Vaccines Did Not Reduce Autism Cases in California
January 7, 2008
Autism cases continued to increase in California after the mercury-containing preservative thimerosal was eliminated from most childhood vaccines, according to a report in the January issue of Archives of General Psychiatry, one of the JAMA/Archives journals. This suggests that exposure to thimerosal is not a primary cause of autism.

FDA Warnings Affected Prescriptions of Antidepressants to Youth
January 7, 2008
Food and Drug Administration warnings regarding the risk of suicidal thoughts and behaviors in children and adolescents taking antidepressants appear to have had modest and targeted effects on the intended populations, according to a report in the January issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

More News Headlines


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