QRxPharma seeks FDA approval for MoxDuo IR
SYDNEY — Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.
QRxPharma announced that it had filed a regulatory approval application with the Food and Drug Administration for MoxDuo IR (morphine and oxycodone). The drug is designed to release both drugs into the body immediately.
“In just four years, we have successfully moved MoxDuo IR through clinical trials and [FDA new drug application] submission by demonstrating its effectiveness and safety,” QRxPharma CEO and managing director John Holaday said. “Achievement of this milestone clearly establishes the value of this dual opioid product to patients and prescribers, as well as potential partners.
Polyglot Systems, CarePoint partner to help healthcare providers communicate medication instructions
MORRISVILLE, N.C. — Polyglot Systems and CarePoint have partnered to help healthcare providers communicate medication instructions more effectively to patients, the two companies said Thursday.
CarePoint has integrated Polyglot’s Meducation product with its GuardianRx Total Pharmacy & Patient Management System, which will enable GuardianRx users to take advantage of such abilities as generating medication instructions in simplified and easy-to-understand formats in English and 11 other languages. Meducation communicates medication instructions using pictures, which comes in handy for patients who have trouble understanding English or reading.
“The increasingly diverse demographics of the country highlight the need for making medication instructions easily understandable, both for non-English-speaking patients and patients that struggle at higher reading levels,” CarePoint president and CEO Jim Whitney said. “The integration of Polyglot’s comprehensive product with our pharmacy management systems allows customers to more easily meet expanding government requirements while increasing the overall level of patient safety.”
According to the companies, evidence suggests that ineffective medication instructions contribute to diminished health outcomes and higher costs.
“Medication mistakes are the most common form of medical errors in this country, resulting in more than 700,000 emergency room visits and nearly 120,000 hospitalizations,” Polyglot founder and president Charles Lee said. “A recent study has shown that improving medication adherence could save up to $7,800 per patient each year. We are thrilled to partner with a company of CarePoint’s vision [that] recognizes this critical need.”
FDA approves Dr. Reddy’s generic anticoagulant drug
HYDERABAD, India — The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.
Dr. Reddy’s and Brisbane, Australia-based Alchemia announced the FDA approval of fondaparinux sodium injection in the 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL strengths. Alchemia owns the patents covering the process for synthesis of fondaparinux.
The drug is a generic version of GlaxoSmithKline’s Arixtra. Arixtra had sales of about $340 million during the 12-month period ended in May, according to IMS Health.