New from
CDER
• 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 FDA announces a draft guidance to change the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Draft Guidance.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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