Kindred Biosciences (KIN) Submits Safety Technical Section to FDA Related to Mirataz NADA
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Kindred Biosciences, Inc. (Nasdaq: KIN) announced the submission to FDA of the Safety technical section of the New Animal Drug Application (NADA) for Mirataz (mirtazapine 2% transdermal ointment, KIND-010). This is the final major technical section to be submitted for Mirataz. The Chemistry, Manufacturing, and Controls technical section was submitted in May 2016 and the Effectiveness technical section was submitted in August 2016.
In the target animal safety study, Mirataz was generally well-tolerated and no significant safety concerns were identified at 1X, 3X, or 5X the proposed label dose (2 mg/cat applied once daily to the inner pinna of the ear) for 42 consecutive days of transdermal application. At the proposed label dose, topical administration of mirtazapine ointment was associated with mild, reversible skin changes at the site of dose application (ear).
Richard Chin, CEO of KindredBio, stated, "We are pleased to bring Mirataz one step closer to approval. Weight loss in cats is a serious and potentially fatal problem, and there is currently no drug approved for the treatment of this unmet medical need. We believe that, with its excellent efficacy and safety profile, Mirataz will be an important new drug for feline patients. Like our other programs, the Mirataz program was completed ahead of time and on budget. I want to congratulate the KindredBio team and our investigators for their dedication and hard work."
KindredBio also announced the launch of the KindredBio Equine website (www.kindredbioequine.com). This website may also be accessed via KindredBio's homepage (www.kindredbio.com).
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