BioAlliance's Sitavig NDA "receivable" by US FDA

French biotech firm BioAlliance Pharma (Euronext Paris: BIO) has announced the receivability of its Sitavig ( (acyclovir Lauriad; European trade name Sitavir) US registration dossier from the Food and Drug Administration for the treatment of recurrent orofacial herpes.

According to the US registration procedure, the FDA has 60 days from the date of New Drug Application submission to conduct a preliminary review of the registration dossier and to confirm its validity for a substantial review. This preliminary and required step being achieved, the assessment of Sitavig registration dossier by the FDA is now entering its effective phase, the company noted.

“The receivability of Sitavig registration dossier represents a major achievement for the product’s progress in the United States. It also demonstrates the know-how of our preclinical, clinical and regulatory teams who, and for the second time, successfully bring one of our products to phase III and then to evaluation for registration in Europe and the United States as well”, comments Pierre Attali, in charge of strategy and medical affairs at BioAlliance.