Elite Pharmaceuticals Inc. (OTCBB:ELTP) had big news heading into the U.S. Thanksgiving.
The New Jersey-based specialty pharmaceutical company, developing abuse-deterrent opioids and niche generic products, heralded that it received approval from the U.S. Food and Drug Administration (FDA) for the Company’s abbreviated new drug application (ANDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets.
Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual U.S. sales of approximately $447 million according to IQVIA (formerly QuintilesIMS Health) data.
To quote CEO Nasrat Hakim, "Hydrocodone/acetaminophen is a strategic addition to Elite’s pain medicine portfolio. The acetaminophen creates irritation if the product is crushed and taken intra-nasally, thereby potentially providing some intranasal abuse-deterrence according to the FDA."
The stock moved into Tuesday afternoon better in price by three-10ths of a cent, or 3.7%, to 8.5 cents, on volume of 3.2 million shares.
