Connetics' Olux-E (clobetasol propionate) foam, 0.05%, was approved for treating inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Drug Criteria & Outcomes: New FDA Approvals
March 1, 2007
Drug Criteria & Outcomes
FDA recently approved these drugs:
- Connetics' Olux-E (clobetasol propionate) foam, 0.05%, was approved for treating inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. FDA noted the company has already fulfilled the pediatric study requirement for the application, and reminded the company of its commitments to perform two post-marketing studies: a dermal carcinogenicity study and a photocarcinogenicity study.
- Shire's Lialda (mesalamine) delayed release tablets, 1.2g, was approved for induction of remission in patients with active, mild to moderate ulcerative colitis. FDA said Lialda's safety and effectiveness beyond eight weeks has not been established. The company is required to perform a post-marketing pediatric study for treating ulcerative colitis in children of all ages.