FDA Pipeline preview, August 2008


Recent FDA action (through August 2008) related to long-acting depot preparation of testosterone, pancrealipase capsules, human papillomavirus (HPV) quadrivalent (types 6, 11, 16, 18) vaccine, recombinant, tolvaptan, etanercept, ustekinumab, and cysteamine hydrocortisone dual-release table.

Approvable designations

Complete response

Recommended for approval

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