Mylan launches generic Invega
PITTSBURGH — Mylan on Monday announced that it had launched its generic version of Janseen’s Invega (paliperidone) extended-release tablets following final Food and Drug Administration approval.
The tablets will be sold in 1.5-, 3-, 6- and 9-mg dosage strengths. Paliperidone is meant to treat patients with schizophrenia in adults and adolescents (12-17 years of age) and schizoaffectifve disorder.
Invega sales for the 12 months ended June 30 were $606.2 million.
NACDS letter to the editor: Pharmacists can help improve medication adherence
ARLINGTON, Va. — The National Association of Chain Drug Stores on Friday released a response to a Sept. 5 article in The Washington Post about efforts to improve medication adherence through research and patient-focused strategies.
In its letter to the editor, NACDS stated:
“[The article] ’Researchers are trying again to help you take your medicine’ hit the nail on the head about the importance of patients taking their medication as prescribed. Researchers interviewed for the article indicate that medication adherence will not improve 'if patients don't develop the habit of sticking to their medication regimens.'
"But there is a solution.
"Pending bipartisan legislation in the U.S. Senate — S. 776, the Medication Therapy Management Empowerment Act of 2015 — would improve access to medication therapy management services for senior citizens enrolled in the Medicare program. Medicare Part D patients with specific chronic conditions — diabetes, cardiovascular disease, COPD and high cholesterol — would benefit from the education and training of pharmacists and other qualified health practitioners to help ensure that medications are taken appropriately.
"There is overwhelming support and research — including the Centers for Medicare and Medicaid Services and the Congressional Budget Office — showing that filling prescription medications and taking them as prescribed improves medication adherence, resulting in better health outcomes and reduced overall medical costs.
"Continued nonadherence will only generate greater health risks for patients with chronic conditions. This commonsense legislation is key to improving medication adherence and health for these patients."
FDA approves two new diabetes drug treatments
SILVER SPRINGS, Md. — The Food and Drug Administration on Friday approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar control in adults with diabetes mellitus. Both Tresiba and Ryzodeg are manufactured by Novo Nordisk.
"Long-acting insulins play an essential role in the treatment of patients with Type 1 diabetes and in patients with Type 2 diabetes with advanced disease," said Jean-Marc Guettier,bdirector of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with Type 1 and Type 2 diabetes mellitus, with dosing based on the patient’s needs. Tresiba is administered subcutaneously once daily. In clinical trial participants with Type 1 and Type 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Tresiba provided reductions in HbA1c in line with reductions achieved with other long-acting insulin.
Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. In clinical trial participants with Type 1 and Type 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Ryzodeg 70/30 provided reductions in HbA1c equivalent to reductions achieved with other long-acting or pre-mixed insulin.
According to the FDA, Tresiba and Ryzodeg should not be used in those who have increased ketones in their blood or urine. The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.
According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes.