Sagene Pharmaceuticals, Inc. Completes Successful Pre-IND Meeting with FDA for Dual-Action Erectile Dysfunction Drug
9/9/2011 10:55:11 AM
OLDSMAR, Fla.--(BUSINESS WIRE)--Sagene Pharmaceuticals, Inc., a biopharmaceutical company focused on developing combinations of FDA-approved drugs to treat diseases associated with aging, has completed a pre-IND (Investigational New Drug) meeting with the Division of Reproductive and Urologic Products of the FDA to discuss the development plan for SPI-1972, a dual-action combination treatment for erectile dysfunction. The FDA addressed the Company’s questions and provided guidance on the NDA requirements for the SPI-1972 development program. The FDA found the filing of an IND for SPI-1972 acceptable under the 505(b)(2) regulations as a combination product in which the active ingredients have been previously approved individually. The 505(b)(2) regulations provide an accelerated pathway for drug approval.