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Weekly Drug News Round Up - October 10, 2012

Update: Multistate Fungal Meningitis Outbreak

Clinics in 23 states have been identified as receiving the contaminated corticosteroid injection Read More...

Contamination of three lots of preservative-free methylprednisolone acetate, an injectable steroid produced and distributed to 23 states by New England Compounding Center (NECC) in Framingham, Massachusetts has lead to over 11 deaths and 119 reported fungal meningitis infections in people receiving epidural injections as of October 10, 2012. The Centers for Disease Control (CDC) is posting daily updates. NECC has shut down operations and stopped distributing its products as of October 3, 2012. Fungal meningitis is not contagious, and symptoms may include fever, headache, nausea, sensitivity to light, stiff neck, weakness or numbness, redness at injection site, slurred speech or other neurological signs suggesting a possible stroke.

Pooled Data Suggest Alzheimer’s Drug May Have Effect

Experts express concern that treatment and reversal of established dementia due to Alzheimer’s disease may be too late Read More...

Eli Lilly’s solanezumab is an investigational monoclonal antibody that targets amyloid beta protein plaques in the brain of Alzheimer’s patients. Pooled data from two recent studies suggest that solanezumab may have a beneficial effect on cognitive abilities in patients with mild to moderate Alzheimer's disease. However, pooled data from these studies that did not meet their primary endpoints would not be sufficient for U.S. Food and Drug Administration (FDA) approval. The Phase 3 trials lasted 18 months and included more than 2,050 patients with mild-to-moderate Alzheimer's disease from 16 countries around the world.

FDA Cracks Down on Illegal Internet Pharmacies

Courses of action included criminal charges, seizure of illegal product, and removal of offending websites Read More...

Are you unsure about buying prescription drugs online? You certainly have good reason. The U.S. Food and Drug Administration (FDA) has taken action this week on over 4,100 illegal pharmacies that sell illicit or fake drugs over the internet. Worldwide over 18,000 rogue internet pharmacies were shut down as part of a larger global crackdown with the seizure of about $10.5 million worth of pharmaceuticals. The effort involved law enforcement, customs and regulatory authorities from 100 countries. Illegal or counterfeit drugs that were seized include the antiviral oseltamivir (Tamiflu), the acne medication isotretinoin (Accutane), and the erectile dysfunction drug sildenafil (Viagra).

FDA Update: Budeprion XL 300 mg Not Equivalent to Wellbutrin XL 300 mg

No new safety data is released, but Budeprion XL 300 mg may not provide the needed effectiveness Read More...

The U.S. Food and Drug Administration (FDA) has reviewed new data that indicate the antidepressant Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA is not therapeutically equivalent to Wellbutrin XL 300 mg. FDA has changed the Orange Book rating for this product from AB to BX, and Impax and Teva have stopped shipping the product. This announcement does not affect the Impax/Teva Budeprion 150 mg product or generic bupropion products made by other manufacturers. Patients taking Budeprion XL 300 mg as a substitute for Wellbutrin XL 300 mg should contact their prescriber.

FDA Approves Cystaran For Rare Genetic Disorder

Cystaran is the only approved ophthalmic treatment for cystinosis that results in organ accumulation of the amino acid cystine Read More...

Sigma-Tau Pharmaceuticals has received approval from the U.S. Food & Drug Administration (FDA) for Cystaran (cysteamine ophthalmic solution) 0.44%, for the treatment of patients with corneal cystine crystal accumulation as a result of cystinosis. Cystinosis is a rare, genetic lysosomal storage disease that affects roughly 300 children and young adults in the U.S. and 2,000 individuals worldwide. Adverse eye reactions occurring in 10 percent or more of patients receiving Cystaran were sensitivity to light, redness, eye pain/irritation, headache and visual field defects. Cystaran will be available through specialty pharmacy channels when launched.

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