FDA's user fee date for action on Solvay's application for re-approval of the obsessive compulsive disorder agent Luvox (fluvoxamine) is early February.

FDA published formal notice of the withdrawal of the Luvox NDA (20-243) in the Federal Register on Aug. 29. Solvay agreed to the withdrawal in May 2002 due to manufacturing compliance and recordkeeping issues (¹ [A#00640210010], p. 17).

The company resubmitted the Luvox NDA in June 2002, expecting it to receive a standard 10-month review. However, because Solvay was on FDA's Application Integrity Policy list, the agency did not begin its review of the Luvox application until April 9, when Solvay was formally removed from the AIP (² 'The Pink Sheet' April 14, 2003, p. 18). That suggests a user fee deadline for the Luvox NDA of Feb. 9, 2004.

FDA also announced the withdrawal of Solvay's NDA (19-919) for the suppository formulation of the ulcerative colitis therapy Rowasa (mesalamine). The company continues to market an enema formulation.

"Solvay has voluntarily withdrawn these NDAs in response to audit findings indicating possible inaccuracies noted in the chemistry, manufacturing and control section of the application," FDA stated. Solvay was placed on the AIP or "fraud policy" list in 1997.

The Federal Register notice includes a formal statement that neither NDA was withdrawn for safety or efficacy reasons. Generic versions of fluvoxamine have been on the market since 2000 and are not affected by the Luvox NDA withdrawal. FDA noted that ANDAs for mesalamine suppositories could still be approved by the agency.

Solvay also faces regulatory challenges for the vasomotor symptom treatment Estratest (estrogen/ methyltestosterone). In an April 14 Federal Register notice, FDA proposed to withdraw the indication for all androgen/estrogen combination agents ("The Pink Sheet" April 14, 2002, p. 17). Solvay has requested a hearing to discuss potential new indications for Estratest, including female sexual dysfunction (³ 'The Pink Sheet' June 9, 2003, In Brief).

Apart from Rowasa enema and Estratest, Solvay continues to manufacture the lithium formulation Lithobid at its Baudette, Minn. facility.

Solvay Luvox Resubmission Has February Deadline; Rowasa NDA Withdrawn

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