Nipro Diagnostics gets FDA approval for blood-glucose monitors
FORT LAUDERDALE, Fla. — Nipro Diagnostics announced that the Food and Drug Administration approved its True Metrix self-monitoring blood-glucose system, as well as the True Metrix Pro professional monitoring blood-glucose system. The company made the announcement at the National Association of Chain Drug Stores Total Store Expo in Boston.
The meters use pre- and post-meal tags that allow patients to mark results to help better understand how food affects blood glucose. Patients also are able to tie noteworthy events — exercise, medication, sickness and other occasions — to blood glucose readings to determine patterns and trends, helping them to make better decisions in the management of diabetes, the company said.
“It is essential as the store brand leader in diabetes that we continue to innovate from both a technology and a business perspective. The evolving payer landscape, driven by demands of increased clinical performance and economic accountability, has created a market energized in disruption. The True Metrix blood glucose monitoring platform reinforces our commitment to offer an innovative, affordable solution for diabetes patients to lead healthier lives,” Scott Verner, CEO and president of Nipro Diagnostics, said.
True Metrix will be available through retail, mail and distribution channels beginning fourth-quarter 2014.
FDA approves Iroko’s NSAID for chronic pain
PHILADELPHIA — Pharmaceutical company Iroko announced today that capsules of its anti-inflammatory drug Zorvolex had been approved by the Food and Drug Administration. This version of the drug is intended to manage pain for those with chronic osteoarthritis. Zorvolex was approved in the United States in October 2013 for the treatment of mild to moderate acute pain in adults.
“Expanding the use of Zorvolex beyond acute pain to osteoarthritis pain, a chronic condition, is a testament to Iroko’s continued commitment to developing a low dose NSAID portfolio to address a broad range of unmet patient needs,” said John Vavricka, Iroko’s president and CEO, said. “This second approval for Zorvolex continues to lay the groundwork for our future portfolio, which utilizes a new approach to pain management.”
In reformulating the drug to manage chronic pain, Iroko followed the FDA’s recommendation that non-steroidal anti-inflammatory drugs contain the minimum effective dose that works for the shortest time. The particles of active ingredient diclofenac are smaller than in normal NSAIDs, but absorption isn’t delayed.
“NSAIDs continue to be an integral part of the management for osteoarthritis, the most common type of arthritis, and their use is likely to increase as the U.S. population continues to age and the incidence of osteoarthritis rises,” said Dr. Roy Altman, a rheumatology professor at the University of California, Los Angeles, said. “The approval of Zorvolex is a welcome and meaningful advance and is the first SoluMatrix NSAID option approved by the FDA for osteoarthritis pain.”
Zorvolex for chronic pain is currently available by prescription.
FDA approves Triumeq for treatment of HIV-1
LONDON — ViiV Healthcare announced that the Food and Drug Administration has approved Triumeq (abacavir 600 mg, dolutegravir 50 mg and lamivudine 300 mg) tablets for the treatment of HIV-1 infection. Triumeq is the company's first dolutegravir-based fixed-dose combination.
"ViiV Healthcare is committed to delivering advances in care and new treatment options to physicians and people living with HIV. We are proud to announce this important milestone, marking the second new treatment to be approved in the US from our pipeline of medicines," Dr. Dominique Limet, CEO ViiV Healthcare, said.