Healthcare Business Review: Medtronic’s INNOCUOUS FDA Warning, Vivus and Transcept in ORANGE BOOK
Pfizer Inc. (NYSE:PFE) reports that the FDA has extended the action date by three months for the New Drug Application for tofacitinib, which is an investigational oral treatment for adults suffering from moderately to severely active rheumatoid arthritis. Upon approval, the drug would be the first rheumatoid arthritis treatment in a new class of medicines known as Janus kinase inhibitors and also the first new oral disease-modifying antirheumatic drug for the disease in more than a decade. The FDA decided that additional data analyses recently submitted by Pfizer comprise a major modification to the application and will thus require additional time to evaluate. However, the agency has not requested any new studies of Pfizer, and has provided an anticipated Prescription Drug User Fee Act date of November 21, 2012.
Investing Insights: Medtronic Earnings: Fourth Straight Quarter of Profit Growth.
An FDA warning letter was sent to Medtronic Inc.’s (NYSE:MDT) division for neuromodulation devices, that was mainly about the company’s processes for handling complaints. Medtronic Chief Financial Officer Gary Ellis explained in a conference call that he does not expect a material impact on financial results from the warning.
Qsymia, made by VIVUS, Inc. (NASDAQ:VVUS) has been posted in the FDA’s Orange Book with a three year expiration exclusivity.
Transcept Pharmaceuticals, Inc. (NASDAQ:TSPT) announced that the FDA has listed its patent for Intermezzo, which is a treatment for middle-of-the-night insomnia, in its Orange Book.
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