Final rules on the monographs for internal analgesics and skin protectant products among significant agency actions that appear closest to release, based on the FDA unified agenda published in the April 27 Federal Register. The agency estimates June publication of the two final rules. Final action on professional labeling for internal analgesics also is targeted for June. The agenda lists April dates for final action on sodium phosphates in laxatives and for a proposed amendment on phosphate labeling for laxatives. Other action that appears to be nearing completion includes a final rule on an amendment on sodium bicarbonate in antacids (slated for August), a proposed warning for antitussive cough/cold products (August) and final action on a warning for overindulgence products (August). Dates in the semiannual agenda are rough estimates and often change...
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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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