U.S. FDA Expands GastroPlus™ Software Licenses
LANCASTER, Calif.–(BUSINESS WIRE)–Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of software for pharmaceutical discovery and development, today announced that it has received a purchase order from the U.S. Food and Drug Administration to expand the number of licenses for the Company’s GastroPlus™ simulation software.
Ron Creeley, vice president of marketing and sales for Simulations Plus, said: “This purchase order increases the number of GastroPlus software licenses at the U.S. Food and Drug Administration by ten new licenses at the Office of Generic Drugs. GastroPlus simulations can provide agency scientists with valuable insight into the dissolution, absorption, and pharmacokinetics of generic formulations compared to innovator formulations when generic drug companies submit abbreviated new drug applications (ANDAs) to the agency. An increasing number of generic drug companies license GastroPlus, and we expect that number to grow. If you’re in the business and you know the regulatory agency is going to analyze your data with GastroPlus, it would behoove you to find out before you submit your ANDA.”
Walt Woltosz, chairman and chief executive officer of Simulations Plus, added: “We enjoy an excellent relationship with many FDA scientists in labs across the country, and we’re pleased that we can provide tools that help the agency in its daunting work of evaluating and approving new medicines. FDA scientists are among the elite in the world of pharmaceutical science, so their selection of Simulations Plus’ software products is extremely satisfying to our scientists, management, and shareholders.”
About Simulations Plus, Inc.
Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development software, which is licensed to and used in the conduct of drug research by pharmaceutical, biotechnology, and drug delivery companies worldwide. The Company has two other businesses, Words+, Inc. and FutureLab™, which are based on its proprietary software technologies. Simulations Plus, Inc., is headquartered in Southern California and trades on the NASDAQ under the symbol “SLP.” For more information, visit our Web site at www.simulations-plus.com.
