Summit Biosciences Announces FDA Approval of ANDA for Sumatriptan Nasal Spray USP, 5 mg and 20 mg
Lexington, KY - February 22, 2016 ' Summit Biosciences Inc., a specialty pharmaceutical company, is pleased to announce that approval of the Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray USP, 5 mg and 20 mg has been received by Lannett Company, Inc. from the U.S. Food and Drug Administration (FDA). Summit developed the product and will manufacture commercial supplies for distribution by Lannett.
Sumatriptan Nasal Spray is a generic equivalent to GlaxoSmithKline's Imitrex® Nasal Spray. Sumatriptan Nasal Spray is delivered from a unique, unit dose nasal spray system.
In June 2015, Summit completed a successful FDA Preapproval inspection for Sumatriptan Nasal Spray. The site was found to be in compliance with current Good Manufacturing Practices (cGMPs) and received no 483 observations. Summit developed the product for commercialization by Lannett Company, Inc., the holder of the ANDA. "Summit's high-tech cGMP facility and expertise in intranasal product development are an excellent match for the Lannett and Summit Sumatriptan project. Lannett's broad pharmaceutical industry experience navigating the FDA approval process to commercialize drug products has been essential in enabling this success," said Greg Plucinski, Chief Operating Officer of Summit Biosciences.
For more information about this FDA approval, follow: Sumatriptan Nasal Spray USP, 5 mg and 20 mg FDA Approval Press Release - Lannett Company, Inc.
About Summit Biosciences
Summit Biosciences Inc. is a specialty pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray drug products. Summit's headquarters and manufacturing facility is located on the University of Kentucky's (UK) Coldstream Research Campus in Lexington, KY. In addition to developing an internal pipeline of products, the company provides a broad spectrum of services and expertise in nasal spray product development, manufacturing and analytical testing to pharmaceutical organizations with the goal of commercializing products for both the generic and branded markets. Along with several generic products, the internal pipeline includes a delta-9 tetrahydrocannabinol (THC or medical marijuana) and products to treat pain. Since inception in late 2009, the company has created over 30 high-tech jobs in the Commonwealth of KY. With this approval and the anticipated commercialization of other Client sponsored and partnered products, Summit anticipates creating many additional high-tech jobs in the next few years.