Premarin shortage possible
Supply shortages of Premarin (conjugated estrogens) may occur in one or more dosage strengths, American Home Products said in its Aug. 14 10-Q filing. On Aug. 8, Wyeth-Ayerst recalled two lots totaling more than 10 mil. tablets of the 1.25 mg strength. The recall is the sixth for dissolution failure since October (1"The Pink Sheet" Dec. 11, 2000, In Brief). Wyeth and FDA are discussing problems associated with failure to meet dissolution standards
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
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In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.