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news.Cipher Pharmaceuticals has submitted an amendment to its pending New Drug Application (NDA) to the US FDA, for its Cip-Isotretinoin, a formulation of the acne medication isotretinoin.
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The company plans to market the product to treat severe, nodular acne, following approval.
Cip-Isotretinoin uses Lidose drug delivery system, which delivers more consistent bioavailability for relatively water-insoluble compounds.
The NDA is backed by pharmacokinetic studies, in which Cip-Isotretinoin demonstrated more consistent absorption under variable dietary conditions compared with existing isotretinoin products.
According to Cipher, the approval by the FDA would spur $1.0m milestone payment from its marketing partner.