Lupin approved for generic Monodox, Cipro
MUMBAI and BALTIMORE — Lupin on Thursday announced that it received final approval from the Food and Drug Administration for its doxycycline capsules USP, 50 mg, 75 mg and 100 mg, which is the generic version of Aqua Pharmaceuticals’ Monodox capsules. The drug is used to treat infections caused by various microorganisms and as an adjunctive therapy in severe acne, according to the company.
The company also received FDA approval for its ciprofloxacin for oral suspension 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500-mg/5-mL), a generic form of Cipro for oral suspension from Bayer HealthCare Pharmaceuticals. The drug is used for the treatment of infections caused by susceptible isolates of the designated microorganisms in various conditions and patient populations, the company said.
Monodox capsules had annual sales in the United States of 180.6 million for the year ending December 2013, according to IMS MAT data; Cipro oral suspension had sales of $8.6 millon.
Study: Participation in diabetes education associated with greater ability to self-manage
LIVERPOOL, England — Study results announced Thursday by Novo Nordisk and collaborative partners found that participation in diabetes education is associated with a greater sense of well-being and the ability to self-manage diabetes.
However, more than three-quarters of people with diabetes in the United Kingdom (78%) have never attended a diabetes education program, and family members are rarely included (79%). Additionally, only 14% of healthcare professionals say that all their patients with diabetes are offered structured diabetes education classes.
The findings of the DAWN2 study show that more than a quarter (26%) of people with diabetes experience diabetes-related distress. Yet family members also experience distress, with around half (47%) worrying about low blood sugar (hypoglycaemic) events, and nearly 1-in-10 (9%) family members likely having depression.
The DAWN2 global study of diabetes was conducted among 15,000 people in 17 countries, including 900 people with diabetes, family members, caregivers and healthcare professionals in the United Kingdom.
“DAWN2 reveals the burden on families of those living with diabetes. Families are worried about their loved one’s future, fearful about aspects such as hypoglycaemia, and keen to help when it comes to self-management," said Simon O’Neill, director of Health Intelligence at Diabetes UK and DAWN2 steering committee member. "We must take a person-centered approach to diabetes care that includes all those involved — the individual, their family network and the healthcare professional community. We need to work together to create a plan of care based on the person’s individual needs."
In response to these findings, a national action plan has been launched to help improve diabetes care in the United Kingdom. The DAWN2 action plan has been developed by an independent, multidisciplinary group with the support of Novo Nordisk, and will provide innovative tools and resources to people living with and caring for diabetes, as part of a three-year program.
21 health industry groups address FDA on proposed changes to generic drug label rules
WASHINGTON — In anticipation of the March 13 deadline for comments on the FDA’s proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation.
“Groups from every part of the healthcare supply chain agree that the Proposed Rule raises serious questions about patient safety, cost and access," said Ralph Neas, president and CEO of the Generic Pharmaceutical Association. "That is why pharmacists, chain drug stores, distributors, pharmacy benefit managers, suppliers, healthcare advocacy groups and others are joining us and saying, ‘We can do better,’” he said. “They recognize that by changing the FDA’s long-standing commitment to consistent labeling, this rule could have serious unintended consequences. We are most concerned about the dangerous confusion multiple labels would cause and the increased costs of and reduced access to generic medicines for patients who need them most.”
The letter was signed by the Academy of Managed Care Pharmacy, American Association of Colleges of Pharmacy, American Pharmacists Association, American Society of Health-System Pharmacists, Amerinet, AmerisourceBergen, Cardinal Health, Cardiovascular Research Foundation, CVS Caremark, Express Scripts, H. D. Smith, Healthcare Distribution Management Association, Healthcare Supply Chain Association, Mckesson, MedAssets, National Association of Chain Drug Stores, National Coalition on Health Care, Novation, Pharmaceutical Care Management Association, Premier Healthcare Alliance and Walgreens.
“Especially noteworthy are the associations representing more than 100,000 pharmacists and more than 40,000 pharmacies who signed on to the letter,” Neas noted. “No one understands better than pharmacists the potential harm this proposed rule could engender. They are the ‘on the ground’ trusted experts who dispense more than three billion generic medicines that Americans use every year. The FDA should listen carefully to their concerns.”
The signatories call for FDA to consider the public health impact of the draft rule. The letter reads: “The FDA and others need to fully explore the potential unintended consequences that the rule may have on patient access and national health care costs. Permitting labeling changes for generic drugs without FDA approval counters 30 years of law requiring generic and brand medicines to have the same labels.”
The letter, addressed to FDA Commissioner Margaret Hamburg, also points out the issue of potential liability for healthcare practitioners, stating: “The Proposed Rule also may expose pharmacists, physicians, generic drug manufacturers and others in the healthcare system to substantial new tort liability costs; these, in turn, would require generic manufacturers to adjust prices to stay in business, withdraw products or decline to launch new affordable versions of brand medicines. This would have a chilling effect on the ability of generic manufacturers and others in the pharmaceutical supply chain to provide affordable medicines to millions of Americans and people across the globe. This is the opposite effect that was intended with the advent of generic medications.”
The letter also pointed to the impact of the Proposed Rule on healthcare system costs, citing a recent study by Matrix Global Advisors. It showed that spending on generic drugs would increase by $4 billion per year (or 5.4% of generic retail prescription drug spending in 2012). Of this, government health programs would pay $1.5 billion, and private health insurance, $2.5 billion.
The letter recognizes the need for a streamlined, efficient process for updating safety information regarding the use of pharmaceutical products for healthcare practitioners and the public, and ends on a positive note, stating, “We believe that simple changes to the proposed rule can achieve all of FDA’s objectives related to efficient communication of important safety information. At this critical juncture, we look forward to working with you and all stakeholders to identify a course of action that does not put patient safety or patient savings at risk.”