Dificid gets nod as CDAD treatment
SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for diarrhea caused by a bacterial infection.
The agency announced the approval of Optimer Pharmaceuticals’ Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea, also known as CDAD.
Clostridium difficile can cause diarrhea and lead to colitis, as well as other serious intestinal diseases and, in severe cases, death. The bacteria are spread by people touching items or surfaces contaminated with the bacteria or spores and then touching their mouths.
Mylan to re-brand Matrix subsidiary
PITTSBURGH — Generic drug maker Mylan plans to give one of its subsidiaries a new name, the company said.
Mylan announced that it would re-brand its Hyderabad, India-based subsidiary Matrix Labs as Mylan. Mylan acquired Matrix in 2007. Since then, the workforce of Matrix, originally founded in 2001, has grown from about 3,800 employees to more than 8,500. The company, founded in 2001, makes a wide variety of generic drugs, including generic antiretrovirals for HIV/AIDS that have been distributed in developing countries under the President’s Emergency Plan for AIDS Relief.
“Throughout the last four years, Matrix has played a unique and important role in Mylan’s transformation into the global and rapidly growing company we are today,” Mylan chairman and CEO Robert Coury said. “Not only has Matrix contributed to Mylan’s very strong growth through the success of its business, it has also made it possible for Mylan to integrate vertically and realize substantial ongoing operational efficiencies on a global basis.”
Solesta approved by FDA as fecal incontinence treatment
SILVER SPRING, Md. — The Food and Drug Administration has approved an injectable gel for fecal incontinence, the agency said.
The FDA announced the approval of Oceana Therapeutics’ Solesta for patients who have involuntarily lost bowel control and for whom such therapies as diet change, fiber therapy and antimotility medications have failed.
Fecal incontinence affects more than 5.5 million Americans, according to the National Institutes of Health.