FDA Update: 6/26/2011

There isn't a lotout of the FDA to note today, but there were a couple of things worth noting. First...

Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor

Ortho-McNeil-Janssen Pharmaceuticals is recalling a lot of Risperidal 3mg tablets and a lot of risperidone 2mg tablets due to potential contamination causing an uncharacteristic odor. The risperidone 2mg tablets are packaged under the manufacturer Patriot. The odor could be caused by 2,4,6 tribromoanisole (TBA). TBA is a fungus which causes a foul. Ortho-McNeil-Janssen is a subsidiary of Johnson & Johnson and has seen a number of recalls related to TBA (including of many of their over the counter products such as Tylenol and Motrin).


FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections

Generic Levaquin (levofloxacin) in the shelves this week. The following manufacturers have approvals for to distribute the medication:

• Akorn Inc.
• Aurobindo Pharma Ltd.
• Dr. Reddy’s Laboratories Ltd.
• Glenmark Generics Ltd.
• Hi-Tech Pharmacal Co. Inc.
• Lupin Ltd.
• Mylan Pharmaceuticals Inc.
• Sagent Strides LLC
• Sandoz Inc.
• Teva Pharmaceuticals USA
• Torrent Pharmaceuticals Ltd.
• Wockhardt Ltd.

That's all for now! 

Cheers

C. Samuels