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 November 15. FDA announces important labeling changes for Mifeprex (mifepristone, also known as RU-486). Mifeprex Info.
  November 12. FDA approves first-time generic Sotradecol Injection (Sodium Tetradecyl Sulfate Injection) for the treatment of small uncomplicated varicose veins of the lower extremities. The reference listed drug is Sotradecol Injection.
 November 8. FDA and Abbott Pharmaceuticals notify healthcare professionals of revisions to the WARNINGS section of the prescribing information for Humira (adalimumab), indicated for the treatment of rheumatoid arthritis. MedWatch Safety Info.
 November 5. FDA announces measures to bolster drug safety evaluations. FDA Statement. Manual of Policies and Procedures (MaPP): Documenting Differing Professional Opinions and Dispute Resolution - Pilot Program.
 November 4. FDA announces a draft guidance to change the generic drug approval process. Draft Guidance.
 November 4. FDA issues a proposed Medication Guide: About Using Antidepressants in Children or Teenagers.
 October 29. FDA approves five first-time generics for Citalopram Hydrobromide Tablets, 10 mg (base), 20 mg (base) and 40 mg (base) to treat depression. The reference listed drug is Celexa.
 October 26. FDA, Janssen Pharmaceutica Products, and Johnson & Johnson Pharmaceutical Research & Development notify healthcare professionals of reports of medication errors involving confusion between Reminyl and Amaryl (glimepiride). MedWatch Safety Info.
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Page Last Updated: November 15, 2004


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