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Not approvable letter issued for Cenestin 0.45-mg tablets.
2003 JUL 3 - (NewsRx.com & NewsRx.net) -- Barr Laboratories, Inc., (BRL) announced that it has received a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) for the company's supplemental New Drug Application (sNDA) for Cenestin (Synthetic Conjugated Estrogens, A) Tablets 0.45 mg, which was under review for the treatment of moderate to severe vasomotor symptoms associated with menopause.
A Not Approvable Letter is issued when the FDA determines that an NDA contains insufficient information for approval at this time. The company said it would seek a meeting with the agency as soon as possible to discuss the application and determine what additional action the company will take.
"While we are disappointed with the FDA's action, we are committed to offering American women a full line of plant-derived ...
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Source: HighBeam Research, Not approvable letter issued for Cenestin 0.45-mg tablets.