Active ingredient(s): palonosetron HCl

Dosage form: 0.25mg/5ml and 0.075mg/1.5ml injectable vials for IV use

Manufacturer: Helsinn

Usage: prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy; and for prevention of postoperative nausea and vomiting for up to 24 hours following surgery

Approval Date: August 22, 2008

For more information visit http://www.aloxi.com/?WT.mc_id=GOPS002&WT.srch=1&s_kwcid=aloxi|1069994644

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

Active ingredient(s): romiplostim

Dosage form: 250 mcg or 500 mcg injectable vials

Manufacturer: Amgen

Usage: Nplate is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to conticosteroids, immunoglobulins, or splenectomy.

Approval Date: August 22, 2008

For more information visit http://www.nplate.com/?WT.srch=151

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

From the FDA MedWatch on August 21, 2008:

FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.

FDA anticipates receiving a final SEAS study report in about 3 months and the Agency’s review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.

Read the complete MedWatch 2008 Safety Summary, including a link to the “Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin); Simvastatin (marketed as Zocor); and Ezetimibe (marketed as Zetia)”, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ezetimibe2

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

 From the FDA MedWatch on August 18, 2008:

Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

Read the complete MedWatch 2008 Safety Summary, including a link to the ‘”Information for Healthcare Professionals” page, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

These were the new generic drugs approved in July.

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

Active ingredient(s): Tetrabenazine

Dosage form: Tablet, 12.5mg and 25mg

Manufacturer: Prestwick Pharma

Usage: effective in the treatment of the chorea associated with Huntington’s Disease.  It is also effective in other movement disorders, including hemiballismus, senile chorea, dystonia and Tourette’s syndrome.  It can also be used to control iatrogenic movement disorders, such as Tardive Dyskinesia.

Approval Date: August 15, 2008

For more information visit http://xenazine.com/prod_xenazine.html

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

You sign up for the Oracea Savings Card online.  The card is reusable and enables most insured patients to pay no more than $25 out of pocket for a 30-day supply of Oracea.  Present your prescription for Oracea and your Oracea Savings Card at the pharmacy.  Under most plans, your co-pay will be between zero and $25.  For patients without prescription insurance, you will receive a $25 rebate per Oracea prescription.   

Get more details at  http://www.oracea.com/Consumer/AboutOracea/OraceaSavings.aspx

Check out our list of coupons for this drug and others at Rx $$$. 

From the FDA MedWatch on August 12, 2008:

FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.

Read the entire MedWatch Safety Summary, including a link to the FDA Drug Information Page regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#naltrexone

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine or treatment.  

From the FDA MedWatch on August 9, 2008:

FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.   Read the complete MedWatch safety summary, including links to the FDA Drug Information page, Information for Healthcare Professionals sheet, and labels (Prescribing Information) for simvastatin and amiodarone products, at http://www.fda.gov/medwatch/safety/2008/safety08.htm#Simvastatin      

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine or treatment.

Active ingredient(s): Flourescein

Dosage form: Light fluorescein formula in 10% or 25% injectable vials or ampules

Manufacturer: Akorn

Usage: indicated in diagnostic flourescein angiography or angioscopy of the fundus and of the iris vasculature.

Approval Date: August 8, 2008

For more information visit http://www.akorn.com/documents/catalog/sell_sheets/17478-253-10.pdf

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.