Announces update on discussions with the FDA related to approval of PennsaidNuvo Research Inc.

Arthritis.announces update on discussions with the FDA related to approval of PennsaidNuvo Research Inc. today provided an update on discussions with the U.S. Food and Drug Administration approval of the recommendation by the FDA on 28 December 2006 used for Pennsaid, a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis.

In a recent meeting with the FDA, the additional requirements for approval as outlined in the approvable letter were discussed. The questions raised in the approvable letter does not reflect the clinical efficacy and clinical safety of Pennsaid, Nuvo in Phase III trials and is the FDA has not requested that Nuvo conduct additional Phase III clinical studies. To resolve certain matters in the approvable letter, the Company is required to generate additional data before approval.To this day, are no scientifically founded evidence to show that baby bedroom setting avoid SIDS controllers. We are wish to ensure that parental, health professionals , and Child Services Contributors be understood the potential risk of choking and using infants sleep the positioner. Please you can visit to submit an incident account and injuries for these products.

Sleep. Suffocation off Infant sleeping positioners, with FDA and CPSC warning.

Parents should be stop babies bed the positioner, caution with FDA and to the Consumer Product Safety Commission. Sofa positioner are devices intended to stop with pillow a baby of roll over. FDA informs that at 12 shall on children from 1 to 4 months of, asphyxiation captive trapped between a sleep positioner and the side of their cradle / toddler bed at the age there.

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