FDA "approvable" letters for dalbavancin, Luvox CR and bazedoxifene

The US Food and Drug Administration has issued an "approvable" letter for dalbavancin HCl, Pfizer's once-weekly two-dose antibiotic under review for complicated skin and skin structure infections. The FDA recently published a draft guidance on studies designed to show non-inferiority as a basis for approval of antibacterials and has requested that the world drug giant provide additional data on the agent, as well as on an issue with a third-party manufacturer and length of storage time. Fellow USA-based Jazz Pharmaceuticals also suffered a delay to its domestic market approval after the regulator issued an "approvable" letter for once-a-day Luvox CR (fluvoxamine maleate) extended-release capsules, which is being co-developed with Belgium's Solvay for the treatment of social anxiety disorder and obsessive compulsive disorder. The FDA requested information related to the companies' response concerning a previously-disclosed chemistry, manufacturing and controls issue. The agency also voiced concerns over US drug major Wyeth's bazedoxifene, a selective estrogen receptor modulator for the prevention of postmenopausal osteoporosis. In its second "approvable" letter on the drug (Marketletter April 30, 2007), the FDA requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events, as well as certain issues relating to data collection, reporting and also requested additional source documents.