ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) Files An 8-K Other EventsItem 8.01 Other Events
On December 15, 2017, Elite Pharmaceuticals, Inc., ("Elite" or the “Company") received a close-out letter from the Food and Drug Administration, Office of Compliance with respect to the August 25, 2016 FDA Warning Letter regarding Post Marketing Adverse Drug Experience (PADE) reporting. The FDA has concluded its evaluation and the corrective actions undertaken by the Company are now complete. There are no longer any potential restrictions from the Warning Letter. Elite remains responsible to continue to maintain compliance with FDA regulations.
On December 4, 2017, the FDA completed a pre-approval inspection for a filed generic product. The inspection was classified as “No Action Indicated” (NAI) because the FDA did not issue any observations.
About ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP)
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company. The Company is principally engaged in the development and manufacture of oral, controlled-release products. The Company develops and manufactures generic products, products using controlled-release drug technology, products utilizing abuse deterrent technologies, and it develops and markets generic controlled-release and abuse deterrent pharmaceutical products. Its segments include Abbreviated New Drug Applications (ANDA’s) for generic products and New Drug Applications (NDA’s) for branded products. The Company owns approximately six different approved ANDA’s. The Company’s product, SequestOx, is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone, which incorporates five milligram, 10 milligram, 15 milligram, 20 milligram and 30 milligram doses of oxycodone into capsules. SequestOx is used for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.