Northvale pharmaceutical company files ANDA

September 27, 2018 by  

Elite Pharmaceuticals, Inc. operates a R&D facility, as well as a manufacturing concern, in Northvale, and recently revealed that it has applied for an Abbreviated New Drug Application (ANDA) for a combination medicine.

Elite is a specialty company that is currently developing opioids used as abuse-deterrent measures, as well as niche generic medicines. Its ANDA will petition the U.S. Food and Drug Administration (FDA) to authorize its development of a generic equivalent to Tylenol with Codeine, which is a combination of acetaminophen and codeine phosphate. Companies that develop products like this, especially since they often need some explanation, can work with a brochure printing company to create an instruction booklet.

The combination medication will be used to treat pain of mild to moderate severity, which can also be treated with opioids, but which are not successfully treated by alternative means. Elite’s chairman and CEO, Nasrat Hakim, says the company is continuing to enlarge its portfolio of medications designed to manage pain. He also explains that the acetaminophen can irritate the nasal passages if the drug is crushed and inhaled, which may help deter its use in such a manner.

Elite is currently developing proprietary products that deter opioid abuse, along with its other products. The company specializes in controlled release and oral-sustained release drugs, and some of its products have been leased to other pharmaceutical companies.