Warner Chilcott plc announced that it has received a complete response letter from the US Food and Drug Administration (FDA) to its New Drug Application submitted in March 2009 for its "low dose" oral contraceptive (also referred to as WC 3016).
The letter states that during FDA inspections of the third-party drug substance manufacturing facility and control testing laboratory used to support the application deficiencies were noted that remain unresolved. Satisfactory resolution of these deficiencies is required before the application can be approved. No efficacy or safety issues were raised by the FDA in the letter.
Warner Chilcott intends to work closely with the FDA and its third-party partners whose facilities were cited in the complete response letter to resolve these issues as rapidly as possible. Until that time, the company's primary promotional focus within the US hormonal contraceptive market continues to be LOESTRIN 24 Fe.
Warner Chilcott is a leading specialty pharmaceutical company currently focused on the gastroenterology, women's healthcare, dermatology and urology segments of the US and Western European pharmaceuticals markets.