Posts Tagged ‘FDA’
New Warning Labels for Epilepsy Drugs Coming Soon
Posted by aranya | Filed under Uncategorized
The FDA is preparing to put warning labels on epilepsy drugs that will notify users about the increased risk for suicidal behavior.
“Everything points in the direction of an increase in what we call suicidality,” said Dr. Russell Katz, director of the FDA’s neuropharmacological drug division in a Katz said in a June 6 Wall Street [...]
Recent New Drug Applications
Posted by aranya | Filed under Uncategorized
Here are the most recent drug applications submitted to the FDA for approval. I always find it interesting to see what’s coming our way.
Sancuso (granisetron) Transdermal Patch Company: ProStrakan Group; Treatment for: Nausea/Vomiting – Chemotherapy Induced. Sancuso (granisetron) is an anti-emetic transdermal delivery system in development for the treatment of chemotherapy-induced nausea and vomiting without [...]
Cloretazine Shows Some Promising Results
Posted by aranya | Filed under Uncategorized
Vion Pharmaceuticals announced the interim data results of its pivotal phase II trial of cloretazine, an anticancer agent drug that is intended to treat elderly patients with de novo poor-risk acute myelogenous leukemia (AML) today. 35 percent of the 85 patients evaluated in the study responded to the drug treatment, and 90 percent of those [...]
A Little Scary…
Posted by aranya | Filed under Uncategorized
On May 27, the FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets or blister cards of 2 tablets. The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction.
“The product [...]
May Drug Approvals
Posted by aranya | Filed under Uncategorized
So, just to keep up with my occasional updates on FDA drug approvals, I feel compelled to point out that May was a bumper month for new drugs – 166 approvals in total!
The list is way too long to go over in detail, but, wow. 166 new approvals in one month? If that is the [...]
Better Warning Labels May Be On the Way
Posted by aranya | Filed under Uncategorized
The Food and Drug Administration has proposed a mandate that would require prescription medicines to have more detailed warning labels than they currently do. In a May 28 USA Today Article, Deputy Director of the FDA’s Office of New Drugs Sandra Kweder said pregnant women in particular need much better guidance.
“Women take an average of three [...]
1-800-SIDE EFFECTS
Posted by aranya | Filed under Uncategorized
Reuters recently reported that some people are pushing for a side effect hotline that would allow patients to phone in particularly dicey drug complications free of charge.
“The 1-800-FDA-1088 number is part of the agency’s MedWatch program to monitor possible problems with drugs and devices. Consumers and doctors can also report concerns on the FDA’s website.
Last [...]
FDA Approves Strattera
Posted by aranya | Filed under Uncategorized
Eli Lilly and Company announced today that the FDA has approved Strattera for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant drug designed to treat ADHD in children, adolescents and adults.
Unlike other ADD and ADHD medications such as Adderall and Ritalin, which [...]
Had a heart attack? Here’s $200,000. Now go away.
Posted by aranya | Filed under Uncategorized
According to a Wall Street Journal article pharmaceutical manufacturer Pfizer has settled some of the lawsuits over two of its painkiller medicines, Celebrex and Bextra. Former users of the drugs allege that they caused heart attacks and strokes. Apparently, there have been an estimated 7,000 to 9,000 Celebrex and Bextra lawsuits filed against Pfizer, and [...]
Blockbuster Cholesterol Drug A No-Go
Posted by aranya | Filed under Uncategorized
The FDA denied approval of the much anticipated Merck & Co. cholesterol drug Cordaptive on Monday, stating that more information on the drug is needed, and that the trade name Cordaptive is not acceptable.
Merck is also the creator of the controversial cholesterol drug Vytorin, which came under fire in January when studies showed that the [...]
