Sun Pharma awaits USFDA approval for cancer drug Lipodox
New Delhi: After gaining market access under a contingency plan by the USFDA, drug major Sun Pharmaceutical Industries is awaiting approval from the health regulator for its cancer drug Lipodox.
The company's temporary supply of the drug to the US is set to come to an end with the US Food and Drug Administration (USFDA) restoring supply of Doxil from Janssen Products, LP after it was stopped earlier this year due to manufacturing and quality issues.
"We have an ANDA awaiting approval with the USFDA, but when to clear the application is entirely the agency's decision," a spokesperson of Sun Pharmaceutical said.
The USFDA had under exercise of enforcement discretion decided in February this year to import Lipodox as an alternative to Doxil after it found manufacturing and quality issues at BVL facility that was making Doxil for Janssen Products LP, a company of drug major Johnson & Johnson.
"FDA anticipates that the incoming supply of Lipodox will be able to fully meet patient needs," the regulator had said.
With Johnson & Johnson indicating that it is restoring the supplies of its drug Doxil, Sun Pharma's export of the drug to the US will come to an end.
In a letter dated October 15, 2012 addressed to healthcare providers, Janssen Products LP, pharmaceutical company of Johnson & Johnson has said, "We are pleased to announce that effective October 15, 2012, Janssen Products, LP is restoring full access to Doxil in the US for physicians and the patients they serve...".
On being asked if Sun Pharma was looking at more approvals in the cancer treatment segment, the spokesperson said: "We have about 135 ANDAs awaiting approval, and it is possible that some of these may be anticancer drugs".
Sun Pharma is a speciality pharma company, with a large presence in the US and India. It has a strong presence in the chronic therapy areas such as cardiology, psychiatry, neurology, diabetology, ophthalmology and orthopaedics among others.