ST. LOUIS, Jan. 26 KV Pharmaceutical(NYSE: KVa/KVb) has been notified that the pending New Drug Application (NDA)for Gestiva(TM) (alpha hydroxyprogesterone caproate) will not be approved bythe U.S. Food and Drug Administration (FDA) until further conditions are met.
As previously disclosed, KV Pharmaceutical entered into a purchaseagreement to acquire the U.S. and worldwide rights to Gestiva upon approval ofthe pending NDA, which was under review by the FDA. The Company previouslyannounced that the date on which the FDA was expected to issue a decision wasJanuary 25, 2009.
The Company has been informed by the current NDA applicant that the FDAwill not approve Gestiva until additional data and information is submittedand accepted. The NDA applicant and the Company have agreed to certain FDA-suggested revisions to the protocol for a post-approval clinical trial thatthe parties had previously agreed to conduct. However, the agency has nowconcluded that an additional condition for approval, among others, will bethat a portion of the study subjects must be enrolled in the study prior tofinal approval. As a result, the Company does not anticipate that it willgenerate revenues from sales of Gestiva during this fiscal year, which ends onMarch 31, 2009.
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceuticalcompany that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceuticalproducts. The company markets its technology distinguished products throughETHEX Corporation, a national leader in generic pharmaceuticals and Ther-RxCorporation, its branded drug subsidiary.
SOURCE KV Pharmaceutical