Flamel Technologies Announces Resubmission of Second NDA

Flamel Technologies S.A. (NASDAQ: FLML) today announced that the company has resubmitted its second new drug application (NDA) to the US Food and Drug Administration (FDA). As Flamel previously announced on May 7, 2013, this second NDA had been filed with the FDA in the first quarter of 2013 and the company received a "refusal to file" letter from the FDA, citing the need to reformat parts of certain datasets in the application. The resubmission of the NDA is consistent with the company's planned timetable. About Flamel Technologies. Flamel Technologies SA's (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery capabilities. The Company has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its partnered pipeline includes biological and chemical drugs formulated with its Medusa® and Micropump® (and its applications to the development of liquid formulations, i.e. LiquiTime™ and of abuse-deterrent formulations Trigger Lock™) proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. The Company has developed products and manufactures Micropump-based microparticles under FDA-audited GMP guidelines. Flamel Technologies has collaborations with a number of leading pharmaceutical and biotechnology companies, including GlaxoSmithKline (Coreg CR®, carvedilol phosphate). The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and manufacturing facilities in Pessac, France. Additional information may be found at www.flamel.com.