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12:00 AM
Dec 05, 2011
 |  BC Week In Review  |  Clinical News  |  Regulatory

Cip-isotretinoin regulatory update

Cipher submitted to FDA an amendment to its NDA for Cip-isotretinoin to treat severe, nodular acne. The company expects a 6-month review for the application. Cipher said the amendment includes data from a double-blind, North American Phase III trial that showed Cip-isotretinoin met the co-primary endpoints of non-inferiority to an...

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