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FDA Approvals - Investigational Drug Paliperidone ER Significantly Delayed Symptom Recurrence In Clinical


Investigational Drug Paliperidone ER Significantly Delayed Symptom Recurrence In Clinical Study Of Patients With (Medical News Today)
Paliperidone extended-release (ER) tablets, an investigational, once-daily oral medication, maintained long-term symptom stability in patients with schizophrenia. Data from a multinational, multicenter phase III study were presented today at the Biennial Congress of the Collegium Internationale Neuro-Psychopharmacologicum (CINP). [click link for full article]

Cyberonics Receives FDA Approval for Harmonized/Modularized VNS Therapy System Labeling Format (SYS-CON Media)
Cyberonics, Inc. today announced that it received FDA approval for a harmonized/modularized VNS Therapy(TM) System labeling format and FDA approval to market the VNS Therapy Model 250 Version 7.1.4 Programming Software in the United States.

Nastech Pharmaceutical Company Receives FDA Communication Concerning Calcitonin-Salmon Nasal Spray (FinanzNachrichten)
BOTHELL, Wash., July 13 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company ( Nachrichten ) Inc. announced today that written notification from the FDA was received on July 10, 2006 stating that Nastech's abbreviated new drug application (ANDA) for intranasal calcitonin-salmon is not approvable at this time.
 

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