USFDA to import cancer drug Lipodox from Sun Pharma
US health regulator has said it will import cancer drug Lipodox from India's Sun Pharma to meet the shortage of another similar medicine Doxil.
New Delhi: US health regulator has said it will import cancer drug Lipodox from India's Sun Pharma to meet the shortage of another similar medicine Doxil.
In response to the critical shortage of the cancer drug Doxil and rapidly declining supplies of methotrexate, the USFDA took proactive steps needed to increase available supply for patients in the US.
"For Doxil, there will be temporary importation of a replacement drug, Lipodox which is expected to end the shortage and fully meet patient needs in the coming weeks," the United States Food and Drug Administration (USFDA) said on its website.
USFDA's exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE and its authorised distributor, Caraco Pharmaceutical Laboratories Ltd, it added.
Doxil is used in multiple treatment regimens, including treatment of ovarian cancer after failure of platinum-based chemotherapy.
"A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration," FDA Commissioner Margaret A Hamburg said.
Temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs, US health regulator said.
Shares of Sun Pharmaceuticals today closed at Rs 544.45 on BSE, down 0.86 per cent from its previous close.