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New Labels For Epilepsy Drugs
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 ...
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Recent New Drug Applications
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 ...
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Cloretazine Shows Promise
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 ...
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A Little Scary…
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 ...
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May Drug Approvals
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 norm ...
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Better Warning Labels?
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 ...
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1-800-SIDE EFFECTS
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 ...
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FDA Approves Strattera
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, ...
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High-Priced Heart Attacks
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 ...
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Cholesterol Drug A No-Go
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 ...
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End Of A Marriage
Schering-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 an application for a ...
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Heparin
According to an April 21 AP article, the FDA issued a warning Monday to Changzhou SPL, the company that manufactures the blood-thinning drug Heparin. The FDA informed the pharmaceutical manufacturing company that it is not doing an adequate job of removing impurities from the raw materials it uses. However, the company maintains that it does ...