- Senate passes Drug Quality and Security Act
- GPhA: FDA’s proposed rule on prescription drug labeling adds $4 billion to healthcare costs
- NACDS, NCPA, GPhA express support for Drug Quality and Security Act
- Ensuring access to chronic pain medications
- Roxane Labs' generic prostate drug gets tentative approval from FDA
NEW YORK Government officials said problems have arisen with the Food and Drug Administration’s approval of a generic blood-thinning drug due to its previous relationship with the generic drug’s manufacturer, according to published reports.
According to The Wall Street Journal, a congressional committee was planning to release a report Tuesday showing that the FDA created the appearance of compromised integrity in its review and approval of an applicaton for a generic version of Sanofi-Aventis’ Lovenox (enoxaparin) submitted by Momenta Pharmaceuticals and Sandoz because Momenta had provided free consulting work in 2008 while the agency was investigating contaminated supplies of the blood thinner heparin imported from China. Sandoz, the generics arm of Swiss drug maker Novartis, is co-marketing the generic version of Lovenox with Momenta.