FDA holds off decision on psoriasis drug - - DermatologyTimes

ADVERTISEMENT

Dermatology Times
FDA holds off decision on psoriasis drug


Dermatology Times E-News

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.

ADVERTISEMENT

Practice ToolsPractice Tools
Coding Counselor
Coding Counselor

Simple and accurate ICD-9 code search. Start Here

Patient Education
Patient Education

Print customized patient education handouts. Start Here

Surgical Video Center
Surgical Video Center

On-demand surgery demos and presentations. Start Here

ADVERTISEMENT



Source: Dermatology Times E-News,
Click here