FDA
« Previous EntriesNew Warning Labels for Epilepsy Drugs Coming Soon
Sunday, June 8th, 2008The 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
Tuesday, June 3rd, 2008Here 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
Tuesday, June 3rd, 2008Vion 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…
Monday, June 2nd, 2008
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
Monday, June 2nd, 2008So, 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 [...]
1-800-SIDE EFFECTS
Wednesday, May 21st, 2008Reuters 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
Friday, May 9th, 2008Eli 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.
Sunday, May 4th, 2008According 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
Tuesday, April 29th, 2008The 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 [...]
The End of An Arranged Marriage
Monday, April 28th, 2008Schering-Plough and Merck have been making moves to bring their two respective allergy drugs — Claritin and and Singulair — together to form one super-drug, but it according to a recent Wall Street Journal article, it doesn’t look like that is going to happen. On April 25, the company said late the FDA had rejected [...]
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