Generic topical corticosteroids

In summary, the three bioequivalence approaches that are currently consistently accepted by regulatory authorities are bioequivalence studies with clinical endpoints, in-vivo pharmacodynamic studies (in particular VCA for topical corticosteroid products), and waivers for topical solutions. Also, most require pharmacokinetic studies if there are safety concerns relating to systemic exposure. However, it is refreshing to see that the regulatory authorities are giving credence to alternative science-based methods for demonstration of bioequivalence, rather than insistence on clinical endpoint studies.

  1. Massage about 1 or 2 teaspoonfuls of shampoo into wet scalp.
  2. Allow to remain on scalp for 2 to 3 minutes.
  3. Rinse scalp thoroughly.
  4. Repeat application and rinse thoroughly.
  5. After treatment, wash hands well.
  6. Repeat treatments as directed by physician.
WARNINGS AND PRECAUTIONS: For External Use Only. Do not use on broken skin or inflamed areas. If allergic reactions occur, discontinue use. Avoid getting shampoo in eyes or in contact with genital area and skin folds as it may cause irritation and burning. These areas should be thoroughly rinsed after application. Keep this and all medicines out of reach of children.

Generic topical corticosteroids

generic topical corticosteroids

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