Food and Drug Administration is seeking more clinical data on the company’s CIP-Isotretinoin acne medication. Cipher said it will appeal the regulator’s position on its new-drug application, but its stock value tumbled. The company said the most recent letter from the FDA indicated that Cipher’s application is approvable subject to resolution of two remaining issues. Cipher shares were down 60 cents or 15 per cent to $3. read more

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TORONTO (Reuters) - Cipher Pharmaceuticals’ chief executive said on Friday he was confident the company could satisfy all regulatory concerns about its acne medication after the U. Earlier in the day, the company said its new drug application related to CIP-Isotretinion, a formulation of the acne medication isotretinoinis, was approvable subject to two outstanding issues — a question on chemistry, manufacturing and controls, and a request for additional clinical data. The company’s president and chief executive, Larry Andrews, said the company expects to file an appeal with the FDA in “the coming weeks. The company has not publicly set a timetable for the launch of the product and Andrews said it would wait until after getting a response to its appeal to do so. read more

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