Sandoz first to receive FDA approval for Lovenox generic
SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected drug used to treat deep vein thrombosis, the agency said Friday.
The FDA approved generic enoxaparin sodium, a version of Sanofi’s Lovenox, developed under a collaboration between Momenta Pharmaceuticals and Sandoz, the generics division of Swiss drug maker Novartis.
Notably, because of the complexity of Lovenox, derived from heparin, the generic version’s approval required a number of complex analytical tests and a clinical study, according to the FDA.
“Sandoz is the first company to launch generic enoxaparin sodium in the U.S., delivering on our strategy of being first-to-market with key products, and underscoring our leadership in differentiated products,” Sandoz global head Jeff George said. “We welcome the FDA decision to approve our enoxaparin application and are now looking forward to significantly increasing patient and payer access to this vital medicine by providing a high-quality, more affordable version.”
Lovenox had U.S. sales of $2.7 billion in 2009, according to Sanofi financial data.
Independent pharmacies tap into long-term care market with new center
DENVER Healthcare services company Cardinal Health will work with the American Society of Consultant Pharmacies to help independent retail pharmacies tap into the long-term care market, Cardinal said Thursday.
According to statistics from 2008, the number of adults in the United States needing nursing home or assisted living care is expected to be 20 million by 2050. Officially launched at Cardinal’s Retail Business Conference in Denver this week, the Long Term Care Specialized Care Center will give independents access to long-term care field specialists, discounts on the ASCP’s policy and procedure manuals and continuing education courses and market analyses.
“Many independent pharmacists want to start serving the high-growth long-term care market, but doing so requires a specialized knowledge base and skill set,” Cardinal VP market management and product development Jay Williams said. “That’s why we’ve partnered with ASCP – the recognized expert in geriatric pharmacotherapy – to provide our customers with the education and building blocks they need to immediately start serving the medication needs of the long-term care facilities in their communities.”
GSK joins the National Pharmaceutical Council
WASHINGTON British drug maker GlaxoSmithKline is the latest company to join health policy research organization the National Pharmaceutical Council, the NPC announced Thursday.
Established in 1953, the NPC sponsors and conducts scientific analyses of the use of drugs with support from drug companies. GlaxoSmithKline SVP private, public and institutional customers Jack Bailey will serve as the company’s representative on the NPC’s board of directors.
“As the nation moves forward with the implementation of healthcare reform, NPC’s research provides policy makers and implementers with keen insight on comparative effectiveness research and health-and-wellness issues,” Bailey said. “I welcome the opportunity to work with NPC and its staff as they move forward with these and other research areas impacting the pharmaceutical industry.”