Barr Laboratories saw its share price fall yesterday, after the US Food and Drug Administration knocked back its Bijuva vaginal cream in treating menopause-related vulvar and vaginal atrophy.
A “not approvable” letter usually requires the submission of additional clinical data, and Barr says it is working with the US agency to resolve outstanding issues – although no more details were revealed.
The product was developed by Duramed Pharmaceuticals, a unit of Barr, and its president Carole Ben-Maimon said: “Although we are disappointed in the agency’s decision, we are confident that the matters raised in the agency’s not approvable letter can be resolved.” The company currently markets the hormone replacement therapy Cenestin and expects to launch a new product, Enjuvia, next year.
