Packaging contributes to approval for Sagent's heparin

Sagent Pharmaceuticals CEO Jeffrey Yordon credits innovative packaging and labeling for the recent FDA approval of nine of the company's heparin products. All feature the company's PreventIV Measures packaging, which aids users in distinguishing between the nine presentations.

PreventIV Measures labeling uses a unique color for each total strength; prominent display of drug name, concentration and fill volume; and all-sides carton printing. The intent is to make it easier for users to differentiate drugs from others in the same class--even those that look and sound alike--and to distinguish between doses.

Heparin is a commonly used anticoagulant that has traveled a bumpy road since contamination incidents in 2007 and 2008 proved fatal. The incidents have been linked in the press and elsewhere to unscrupulous Chinese suppliers, but no legal action has been taken. The supply problems led to a reformulation to aid manufacturers in detecting impurities, but the drug became less potent in the process. The reduced potency led to an FDA alert to healthcare providers to adjust dosage as necessary. And the alert coincided with the simultaneous availability of both the older and newer formulations. Just last May, Congress sent a pointed query to FDA Commissioner Margaret Hamburg about the agency's strategy for resolving who contaminated the heparin supply.

- here's the article

Suggested Articles

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.

Eli Lilly is investing $400 million in its Indianapolis site to expand production of insulin and other diabetes meds, and add 100 jobs.

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.