The approval is for doses 8mg, 12mg and 16mg of Exalgo (Hydromorphone Hydrochloride Extended-release Tablets).
The drug is indicated for the management of moderate to severe pain in opioid tolerant patients who need continuous, around-the-clock opioid analgesia for an extended period of time.
The company plans to start shipping its product shortly and believes that, under applicable Hatch Waxman rules, it may be entitled to marketing exclusivity.
With commercial operations in about 60 countries, Actavis is focused on developing, manufacturing and distributing generic, brand and biosimilar products.
The company develops and manufactures generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products.
The company’s North American branded pharmaceuticals business is mainly focused on the Women’s Health, Urology, Gastroenterology and Dermatology therapeutic categories with a strong pipeline of products in several stages of development.