News Feature | September 9, 2014

Actavis' cUTI, cIAI Drug NDA Filing The Latest In Recent Drug Filing Activity

By Lori Clapper

Actavis announced last Friday that the FDA has accepted for review the company's NDA for its ceftazidime-avibactam in Complicated Intra-Abdominal Infections (cIAI), Complicated Urinary Tract Infection (cUTI) and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) indications. The drug garnered attention from the FDA back in August 2013 when it earned Qualified Infectious Disease Product (QIDP) status.

"Today, there exists a serious and unmet need for new options to treat patients suffering from infections due to resistant Gram-negative pathogens, including Carbapenem Resistant Enterobacteriaceae (CRE)," David Nicholson, SVP, Actavis Global Brands R&D, said. 

This news is the latest in a string of recent activity from Actavis, which includes:

  • Last week’s announcement that the U.S. Food and Drug Administration (FDA) accepted for its New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarreah and other symptoms associated with Irritable Bowel Syndrome (IBS-D).  The NDA was also granted priority review status by the FDA.
  • In August, Actavis filed an abbreviated new drug application (ANDA) with the FDA for approval of Rotigotine Extended-release Transdermal Film, a generic version of UCB’s drug Neupro, in August. The drug is manufactured to treat Parkinson’s Disease as well as moderate-to-severe primary restless legs syndrome (RLS). According to Activis, it could be the first company to file an ANDA for the generic version of Neupro and, if the FDA approves the ANDA, the company may be entitled to 180 days of generic market exclusivity. Between June 2013 and June 2014, it was estimated that Neupro had total U.S. sales of nearly $85 million, according to IMS Health data.
  • In July, the company announced that the FDA had accepted for filing an NDA for both Actavis’ and Medicines360's Levosert (levonorgestrel), a hormonal intrauterine contraceptive (IUC) used to prevent pregnancy.

Actavis offers a broad portfolio of both brand-name and generic pharmaceuticals and focuses its medicinal research on diseases in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories.