Tag:
APP Pharmaceuticals
Latest Headlines
Latest Headlines
FDA says APP ignored consumer complaints for 18 months
New details about problems with the production of heparin and other drugs by APP Pharmaceuticals ( $APPX ) have been released by the Food and Drug Administration on its website.
FDA seeks 3 years of heparin test results from APP Pharmaceuticals
APP Pharmaceuticals ( $APPX ) has had its production of heparin called into question in an FDA warning letter and has been ordered to present three years worth of out-of-specification results for...
FDA cites contaminated vials, insects in APP warning letter
The FDA has posted its warning letter about APP Pharmaceuticals' New York plant, and the citations aren't pretty.
Medicines Company, APP settlement includes manufacturing agreement
A fill/finish manufacturing agreement is part of the settlement between The Medicines Co. ($MDCO) and APP Pharmaceuticals ( $APPX ) over generic versions of The Medicines Co.'s lead product, Angiomax.
Analysts ponder takeover of ailing Hospira
Bloomberg speculates generics-maker Hospira ( $HSP ), currently limping with GMP remediation efforts across multiple manufacturing sites, is becoming attractive as a takeover target to other generics
UPDATED:Drugmakers respond to shortages order, HHS report
Generic drugmakers have pledged to work with the FDA to formalize the process for manufacturers and other members of the supply chain to report drug shortages to the FDA, "as many now do
APP, Hospira resolve shortage of cytarabine
One of the many cancer drug shortages--of cytarabine, a treatment for acute myeloid leukemia--has been resolved. Drugmakers APP Pharmaceuticals ( $APPX ) and Hospira ( $HSP ) report "good supply" and
APP taps parent Fresenius' facilities to boost propofol supply
APP Pharmaceuticals ( $APPX ) has boosted production of propofol , long on the FDA's list of drugs in short supply, and reports its two versions of the drug are "readily available." The drugmaker, a
APP Pharma boosts supply of propofol products
APP Pharmaceuticals ( $APPX ) has ramped up production of two versions of propofol, an anesthetic that has been in short supply over the past year. Report
Congress pushes 10 drugmakers for heparin info
Unsatisfied with the information it has drawn from the FDA, a congressional committee is broadening its probe into the years-old heparin contamination scandal. The House Energy and Commerce Committee
