FDA approves Solco Healthcare’s Cymbalta generic
SILVER SPRING, Md. — The Food and Drug Administration has approved Solco Healthcare’s generic of Cymbalta (duloxetine) delayed-release capsules, the company recently announced.
The drug is indicated to treat major depressive disorder in adults, as well as general anxiety disorder in adults and children ages 7 years and older. It also can be used to treat fibromyalgia or chronic muscle or joint pain.
“We are pleased to receive this FDA approval, which adds to our growing line of central nervous system acting agents,” Solco Healthcare president Hai Wang said. “We continue to strengthen our presence within the U.S. generic market by providing high-quality medicines at affordable prices.”
The company said its generic is available now in 20-, 30- and 60-mg dosage strengths. The product had brand and generic sales of roughly $484.4 million for the 12 months ended June 2017, according to QuintilesIMS data.
BioDelivery Sciences’ longtime president, CEO to retire
RALEIGH, N.C. — BioDelivery Sciences International will see its longtime president and CEO retire. The company announced Wednesday that Dr. Mark Sirgo, who has served in these roles since 2005, will be retiring at the end of 2017. He will remain vice chairman of the company’s board of directors. The company said that the board and Sirgo would work to find a successor in the coming months.
"After thirteen years of leading BDSI from a start-up through three drug approvals and the creation of a fully-integrated pharmaceutical company, highlighted by the recent reacquisition and early commercial success of Belbuca, the business is very well positioned for long-term growth,” Sirgo said. “With the outstanding team we have built and the overall strength of the business, year-end felt like the appropriate time for me to retire from my day-to-day role. Announcing my plans now allows for the timely selection and onboarding of my replacement, a proven leader with significant commercial experience, before year-end.”
Sirgo was one of the founder of Arius Pharmaceuticals, which merged with BioDelivery Sciences in 2004, bringing BDSI the BioErodible MucAdhesive film technology that became the foundation of the company’s product pipeline. He has led the company through the development, approval and launch of Onsolis, Bunavail buccal film and Belbuca buccal film. The company recently reacquired the rights to Belbuca from Endo.
"Mark's accomplishments during his tenure reflect his commitment to hard work, a continual focus on building a quality pharmaceutical company and unwavering dedication to creating shareholder value,” BDSI chairman Dr. Frank O'Donnell, said. “Mark's leadership and vision for drug development, much of which has been built from the BEMA platform that was acquired when Mark joined BDSI, have been instrumental to BDSI's growth, including three successful drug approvals and the launch of a full commercial organization. We thank Mark for his innumerable contributions to BDSI and look forward to Mark's continued leadership through this transition and his continued guidance as vice chairman.”
CVS Health’s Accordant gets NCQA disease management accreditation for 18 conditions
WOONSOCKET, R.I. — CVS Health company Accordant has received NCQA Patient and Practitioner Oriented Disease Management Accreditation, the company announced Wednesday. The disease management accreditation was given for a number of Accordant’s programs providing services to patients with rare chronic disease and other conditions on behalf of health plans, government-sponsored plans, labor groups, employers and third-party administrators, and covers 18 conditions, including epilepsy, Parkinson’s disease, ALS, HIV, Crohn’s disease and others.
"We are pleased to receive this important accreditation from NCQA, which further validates our approach to providing high-quality and comprehensive disease management care and support for our patients with these rare, chronic conditions," CVS Specialty EVP Dr. Alan Lotvin said. "For more than 20 years, Accordant has been providing highly specialized care to patients to help them better manage their condition, improve health outcomes and help avoid unnecessary medical costs for both patients and payers."
CVS Health said that the accreditation indicates that a disease management program is dedicated to providing support, education and other help necessary to facilitating good outcomes and care. The standards are designed to help organizations achieve the best performance, increase adherence to care guidelines and create an environment for continued improvement, the company said.
"Our Accordant nurses are specially trained to provide disease-specific support to help prevent complications, improve our patients' total health and enhance quality of life," Accordant president Trip Hofer said. "In addition, Accordant's unique, proactive disease management approach helps anticipate shifts in patient needs as their condition progresses over time, which is integral in ensuring each patient receives the most clinically appropriate care and support along their health care journey."
Accordant has maintained NCQA disease management accreditations since 2003, and was awarded case management accreditation in 2016. Accordant’s disease management programs are led by specialized and trained nurses who provide comprehensive patient education, medication and symptom management, as well as coordination of patient care with other healthcare providers.
CVS Health said that its CVS Specialty division is the largest specialty pharmacy, providing advanced clinical services for eligible patients who require treatment for rare or complex conditions.
"NCQA's Disease Management Accreditation program is thorough and rigorous,” NCQA president Margaret O'Kane said. “It's designed to highlight only those programs that truly improve chronic care.’