SUPAC-MR FINAL GUIDANCE INCREASES LEVEL 1 CONTENT VARIATION FROM 2% TO 5% for release-controlling excipients for all extended- and delayed-release solid oral dosage forms. The Scale-Up and Post-Approval Changes guidance for Modified-Release Solid Oral Dosage Forms, finalized on Oct. 6, states that for Level 1 components and composition changes, "the total additive effect of all release-controlling excipient changes should not be more than 5% [by weight] of the total release-controlling excipients in the original approved formulation." Such changes would be filed in an annual report. The draft SUPAC-MR guidance, released in August 1996, only allowed for Level 1 release-controlling excipient changes up to 2% of the total weight ("The Pink Sheet" Aug. 5, 1996, T&G-12).
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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