- Case-Based Roundtable
- General Dermatology
- Eczema
- Chronic Hand Eczema
- Chronic Spontaneous Urticaria
- Alopecia
- Aesthetics
- Vitiligo
- COVID-19
- Actinic Keratosis
- Precision Medicine and Biologics
- Rare Disease
- Wound Care
- Rosacea
- Psoriasis
- Psoriatic Arthritis
- Atopic Dermatitis
- Melasma
- NP and PA
- Skin Cancer
- Hidradenitis Suppurativa
- Drug Watch
- Pigmentary Disorders
- Acne
- Pediatric Dermatology
- Practice Management
- Prurigo Nodularis
- Buy-and-Bill
Article
FDA holds off decision on psoriasis drug
New York - The Food and Drug Administration (FDA) has held off making a decision on the psoriasis drug ustekinumab (Johnson & Johnson), until they receive certain risk-mitigation information, but will not require new studies, Reuters reports.
New York
- The Food and Drug Administration (FDA) has held off making a decision on the psoriasis drug ustekinumab (Johnson & Johnson), until they receive certain risk-mitigation information, but will not require new studies, Reuters reports.
The FDA has issued a Complete Response letter for ustekinumab, which is sometimes issued when the agency needs more time to adequately review a drug, requesting additional information to ensure the drug’s benefits outweight the risks, according to a Johnson & Johnson press release.
The company says the letter also requests a medication guide and communication plan as part of the risk-mitigation information, which Johnson & Johnson says will be addressed next month, as the focus this month is on bringing the drug to market.
Newsletter
Like what you’re reading? Subscribe to Dermatology Times for weekly updates on therapies, innovations, and real-world practice tips.
