Volume 38 - September 2007

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

Totect (dexrazoxane) Injection
Date of Approval: September 6, 2007
Treatment for: Anthracycline Extravasation
Totect is a topoisomerase inhibitor used as a detoxifying agent for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
Totect Drug Information | Press Release

ACAM2000 (Smallpox (Vaccinia) Vaccine, Live)
Date of Approval: August 31, 2007
Treatment for: Smallpox Prophylaxis
ACAM2000 is live vaccinia virus smallpox vaccine intended for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 is the first biodefense vaccine to be approved as part of the US response to the 2001 bioterrorism attacks.
ACAM2000 Drug Information | Press Release

Somatuline Depot (lanreotide acetate) Injection
Date of Approval: August 30, 2007
Treatment for: Acromegaly
Somatuline Depot is a sustained-release injection formulation of lanreotide, a somatostatin analogue indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
Somatuline Depot Drug Information | Press Release

Evithrom (human thrombin)
Date of Approval: August 27, 2007
Treatment for: Bleeding
Evithrom is a highly purified human thrombin used 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.
Evithrom Drug Information | Press Release

Zingo (lidocaine hydrochloride monohydrate) Dermal PowderJect
Date of Approval: August 16, 2007
Treatment for: Local Analgesia
Zingo is a needle-free, local anesthetic intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws, in children three to 18 years of age.
Zingo Drug Information | Press Release

Selzentry (maraviroc) Tablets
Date of Approval: August 6, 2007
Treatment for: HIV Infection
Selzentry (maraviroc) is the first in a class of drugs known as CCR5 antagonists, approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood (viral load).
Selzentry Drug Information | Press Release

More FDA Approvals


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

Evista (raloxifene HCl) Tablets
New Indication Approved: September 13, 2007
Treatment for: Reducing Risk of Invasive Breast Cancer
Evista is a selective estrogen receptor modulator or SERM (recently classified by the FDA as an estrogen agonist/antagonist). Evista was first approved in December 1997 for the prevention and treatment of osteoporosis in postmenopausal women. Evista is now also approved to reduce the risk of invasive breast cancer in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer.
Evista Drug Information | Press Release

Risperdal (risperidone)
New Indication Approved: August 22, 2007
Treatment for: Schizophrenia in Adolescents; Bipolar Mania in Children and Adolescents
Risperdal is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Risperdal was first approved December 1993 for the treatment of schizophrenia in adults, for the treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder in adults and for the treatment of irritability associated with autistic disorder in ages 5-16 years. Risperdal is now also approved for the treatment of schizophrenia in adolescents ages 13-17 and for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents ages 10-17.
Risperdal Drug Information | Press Release

Reclast (zoledronic acid) Injection
New Indication Approved: August 17, 2007
Treatment for: Postmenopausal Osteoporosis
Reclast belongs to the bisphosphonate class and acts primarily on bone. Reclast Injection was first approved in April 2007 for the treatment of Paget's disease in men and women. Reclast is now also approved as the first and only once-yearly medicine for postmenopausal osteoporosis. Unlike oral bisphosphonate therapies that have to be taken daily, weekly or monthly, Reclast is given as a once-yearly 15-minute intravenous (IV) infusion. This means with a single treatment a patient can receive a full year's protection against the effects of osteoporosis.
Reclast Drug Information | Press Release


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

Viracept (nelfinavir mesylate)
September 10, 2007

Pfizer issued a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity in Viracept and to provide guidance on the use of Viracept in pregnant women and pediatric patients.

Zencore Tabs September 7, 2007
Bodee LLC, Inc., issued a nationwide recall of Zencore Tabs, a product marketed as a dietary supplement, because it contains undeclared ingredients.

Metabolism Apple Cider Vinegar Brand Dietary Supplement Capsules August 21, 2007
Confidence Inc. informed consumers and healthcare professionals that the company is recalling one lot of METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules (Lot: 3001006, Exp. 10/2009) because the product contains the undeclared drug ingredient sibutramine, an FDA approved drug used as an appetite suppressant for weight loss.

Codeine Products Used By Nursing Mothers August 17, 2007
FDA issued a Public Health Advisory with important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine.

Warfarin (marketed as Coumadin) August 16, 2007
FDA approved updated labeling to include pharmacogenomics information in the prescribing information for the widely used blood-thinning drug, Coumadin. This new information explains that people's genetic makeup may influence how they respond to the drug.

Nonprescription Cough and Cold Medicine Use in Children August 15, 2007
FDA announced that on October 18 - 19, 2007, the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under two years of age.

More FDA Medwatch Alerts


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

FDA Approves Levaquin Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis September 17, 2007
The U.S. Food and Drug Administration (FDA) has approved use of the five-day, once-daily regimen of Levaquin (levofloxacin) 750 mg I.V. and oral, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).

Cephalon Reinforces Important Prescribing and Dosing Information for Fentora September 13, 2007
Cephalon, Inc. today communicated with healthcare professionals to clarify the appropriate patient selection, dosing and administration for Fentora (fentanyl buccal tablet) [C-II]. The company is sharing this information with the medical community to reinforce the appropriate prescribing and use of the medication. The letter, issued in collaboration with the U.S. Food and Drug Administration (FDA), was in response to recently reported serious adverse events, including some deaths in patients who were not appropriate candidates for Fentora. These events appear to have occurred as a result of improper use in patients who were not already taking opioids around-the-clock (opioid nontolerant); improper dosing of the medication; and/or improper substitution of Fentora for other fentanyl-based medications.

FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol September 12, 2007
Today, the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) held a meeting to discuss the risk /benefit profile of Trasylol (aprotinin injection), a Bayer drug used in coronary artery bypass graft (CABG) surgery. At the close of the meeting, based on the Trasylol data in Bayer's controlled clinical studies and after considering data from observational studies and public testimony presented at the meeting, the Committees recommended that U.S. marketing authorization for Trasylol should be continued.

FDA MedWatch: Potential Risk Associated With Concomitant Use Of Rocephin With Calcium Containing Products September 11, 2007
Roche informed healthcare professionals about revisions made to the prescribing information for Rocephin to clarify the potential risk associated with concomitant use of Rocephin with calcium or calcium-containing solutions or products. Healthcare professionals are advised that Rocephin and calcium-containing solutions including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. Rocephin and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient.

Adverse Drug Events Reported to FDA Appear to Have Increased Markedly September, 10, 2007
The number of serious adverse drug events reported to the U.S. Food and Drug Administration (FDA) more than doubled between 1998 and 2005, as did deaths associated with adverse drug events, according to a report in the September 10 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. A serious adverse drug event, as defined by the FDA, means an adverse event that resulted in death, a birth defect, disability, hospitalization, or was life-threatening or required intervention to prevent harm, according to background information in the article. Such events are voluntarily reported to the FDA through its Adverse Event Reporting System (AERS) and known as "MedWatch" reports. The reports come to the FDA directly or through drug manufacturers, who are then required to forward them.

Youth Drug Use at a Five Year Low, New Survey Shows September 6, 2007
Overall illicit drug use among teens ages 12-17 is at a five year low, according to the largest and most comprehensive study of drug use in the United States, released today. But when it comes to youth, nonmedical use of painkillers continues to be an area of concern, with more recent initiates (2.2 million) than any illicit drug, reveals the National Survey on Drug Use and Health (NSDUH).

FDA Approves First Generic Versions of Coreg September 5, 2007
The U.S. Food and Drug Administration today approved the first generic versions of Coreg (carvedilol). Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack.

Shire Voluntarily Withdraws a Limited Portion of Daytrana Patches September 4, 2007
Shire plc announced today the voluntary market withdrawal of a limited amount of the ADHD patch Daytrana; only Daytrana packages with an expiration date of March 31, 2009 or earlier and Daytrana packages with lot numbers 2563511, 2563611, and 2570411 are impacted by this voluntary market withdrawal. Shire is taking this proactive step not due to safety and efficacy issues, but due to feedback from patients and caregivers who have experienced difficulty removing the release liner from some Daytrana patches.

National Asthma Guidelines Updated August 29, 2007
The National Asthma Education and Prevention Program (NAEPP) today issued the first comprehensive update in a decade of clinical guidelines for the diagnosis and management of asthma. The guidelines emphasize the importance of asthma control and introduce new approaches for monitoring asthma. Updated recommendations for managing asthma include an expanded section on childhood asthma with an additional age group, new guidance on medications, new recommendations on patient education in settings beyond the physician's office and new advice for controlling environmental factors that can cause asthma symptoms.

Statin Treatment May Curb Alzheimer's Brain Changes August 27, 2007
People who take statin drugs may be less likely to develop the brain changes that signal Alzheimer's disease, according to a study published in the August 28, 2007, issue of Neurology, the medical journal of the American Academy of Neurology.

Study Finds Viagra Increases Release of Key Reproductive Hormone August 23, 2007
Researchers at the University of Wisconsin-Madison report this month that sildenafil increases the amount of oxytocin released by stimulation of the posterior pituitary gland, a small structure directly underneath the brain that regulates hormone levels in response to neural signals. The finding is the first indication of a chemical mechanism through which erectile dysfunction drugs like Viagra may have physical effects besides increasing blood flow to sexual organs, says study author Meyer Jackson, a physiology professor at the UW-Madison School of Medicine and Public Health. Sometimes called the "love hormone" or "cuddle chemical," oxytocin plays several important roles in social interactions and reproduction, including triggering uterine contractions and lactation. It is also released during orgasm and has been linked to sexual arousal.

PCMA: Minnesota is First in the Nation to Require E-Prescribing August 20, 2007
In a signal of momentum for greater use of e-prescribing by America's physicians, the state of Minnesota has taken steps to require physicians contracting with the state employee health plan's medical networks to use e-prescribing by 2011, said the Pharmaceutical Care Management Association (PCMA) today. Last year the Institute of Medicine challenged all physicians to begin using e-prescribing to reduce the 1.5 million preventable medication errors that occur each year due to causes such as harmful drug-drug interactions, unawareness of patients' medication history and illegibly written prescriptions.

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