Aurobindo receives approval for generic Razadyne, Monopril
HYDERABAD, India — Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.
The company said Wednesday that it received approval for galantamine tablets in the 4-, 8- and 12-mg strengths. The drug is a version of Johnson & Johnson’s Alzheimer’s treatment Razadyne; various versions of the drug had sales of $41 million during the 12 months ended in September 2010, according to IMS Health.
On Thursday, the FDA approved Aurobindo’s fosinopril sodium tablets in the 10-, 20- and 40-mg strengths. The drug is a generic version of Bristol-Myers Squibb’s Monopril and is used to treat hypertension. Versions of the drug had sales of $20 million during the 12-month period ended in September 2010, according to IMS.
High blood-glucose levels linked to retinopathy
NEW YORK — Patients diagnosed with high blood-glucose levels that cannot control the condition over time likely will develop such eye-related complications as retinopathy 10 years later, according to a report in the February issue of Archives of Ophthalmology.
A study led by Pascale Massin of Hôpital Lariboisière in Paris and colleagues found that after examining the retinas of 700 men and women — noting that 235 patients had diabetes, 227 patients had an impaired fasting plasma glucose level and 238 patients always had glucose levels within normal limits — 44 participants were classified as having retinopathy, including 19 patients with diabetes, 19 patients with impaired fasting glucose levels and six patients with normal glucose levels. What’s more, those with the retinopathy had higher average levels of fasting plasma glucose 10 years prior (130 mg versus 106 mg per deciliter) and higher HbA1C levels (6.4% versus 5.7%).
"Levels of HbA1C and fasting plasma glucose at baseline were related to the presence of retinopathy 10 years later, and the levels at which the positive predictive values increased provide a rationale for the choice of thresholds for the definition of hyperglycemia associated with 10-year retinopathy," the authors wrote. "Factors other than glucose measures play only a minor role in retinopathy."
Congressman saluted by HDMA
ARLINGTON, Va. — The Healthcare Distribution Management Association on Tuesday honored Rep. John Shimkus, R-Ill., with its Rx Safety and Healthcare Leadership Award. The award recognizes public officials for their leadership and commitment to policies that support and promote the safe and efficient delivery of medicines.
Shimkus has been a consistent supporter of policies that enhance healthcare supply chain security and efficiency, the association stated. For example, he is an original co-sponsor of bipartisan legislation (H.R. 905) to correct the treatment of prompt pay discounts under the Medicare Part B average sales price reimbursement metric for prescription drugs and biologics. The legislation would enhance patient access to these medications and increase supply chain efficiencies that distributors provide to the healthcare system when servicing physicians who participate in the Part B program, HDMA noted.
“Congressman Shimkus recognizes the critical role of HDMA distributors, who not only deliver lifesaving medications safely and efficiently, but [also] save the nation’s healthcare system $32 billion annually,” stated HDMA president and CEO John Gray.