Subscribe to RSS

Doxil Generic Version Approved by U.S. Regulatory Agency

Posted on 05. Feb, 2013 by in Health, Health Featured

The U.S. Food and Drug Administration announced on Monday the approval of a generic version of Doxil, the cancer drug

The U.S. Food and Drug Administration announced on Monday the approval of a generic version of Doxil, the cancer drug

February 05, 2013 - The U.S. Food and Drug Administration announced on Monday the approval of a generic version of Doxil, the cancer drug. The approval could help to ease a shortage that has taken place over the last few months, threatening thousands of patients’ lives.

The approval by the U.S. regulatory agency is for the drug generically known as doxorubicin HCI lipsome injection.  The drug is manufactured by a subsidiary of Sun Pharmaceutical Industries in India. The new drug will be made available in vials of 20 and 50 milligrams.

The product by Sun is the first version of Doxil that is generic. Doxil was approved back in 1995 and treats ovarian cancer, multiple myeloma and Kaposi’s sarcoma that is AIDS-related. Johnson & Johnson manufactures Doxil.

Doxil’s supply became very low after problems in manufacturing occurred at a contract manufacturer outside J&J. Ben Venue Laboratories, the contract manufacturer, which is a part of Boehringer Ingelheim, the German drugmaker, suspended its operations due to problems with quality control in November of 2012.

The FDA, last month, approved the temporary importing of Lipodox, which Sun manufactures and has Doxil’s same active ingredient. The FDA said it would continue allowing Lipodox to be imported until there has been enough generic Doxil made to meet the demand.

A federal judge last month approved a decree that says Ben Venue must improved its Ohio facility or face heavy fines and other penalties. The U.S. regulatory agency said the company repeatedly violated proper manufacturing practices.

Inspections of the manufacturing facilities recently found equipment was poorly maintained and deteriorated to where particles were shed into injectable drugs, said the FDA.

0 comments

Other articlesgo to homepage

AbbVie Beats Estimates during First Quarter

AbbVie Beats Estimates during First Quarter(0)

April 28, 2013 - AbbVie announced on Friday that it could earn up to $1.5 billion more in annual revenue from is rheumatoid arthritis medication Humira, which already makes up 50% of its overall revenue, as new uses are approved for the medication. Humira’s sales during the first quarter were up by 16% from the same

Vaccine Trial for HIV Shuttered

Vaccine Trial for HIV Shuttered(0)

April 26, 2013- Federal researchers have shuttered a clinical trial for a vaccine for HIV that involved more than 2,500 subjects. The trial was ended after researchers found that it was ineffective at preventing subjects who were healthy from contracting HIV. The major setback came about when safety experts from an independent panel determined that

Hundreds of Undocumented Immigrants Sent Home by Hospitals in U.S.

Hundreds of Undocumented Immigrants Sent Home by Hospitals in U.S.(0)

April 24, 2013 - Hundreds of immigrants that were in the U.S. illegally have been transported back to their home countries by hospitals in the U.S. This little known or heard off system of removal is not run by the government, but by individual hospitals who seek to lower their costs. A report recently published compiled

AIDS: 1.8 million children orphaned in Nigeria

AIDS: 1.8 million children orphaned in Nigeria(0)

April 21, 2013 - Medical experts estimate that over 1.8 million children in Nigeria have been orphaned because of AIDS since 1986 when the first case was identified of the pandemic in the country. The Ministry of Health in the country spoke of the problems the children are facing during a five-day workshop to help give

Authorities accuse Glaxo of Paying to delay Generic Medicines

Authorities accuse Glaxo of Paying to delay Generic Medicines(0)

April 19, 2013 - GlaxoSmithKline the UK pharmaceutical giant was accused of paying their rivals to slow production of generic versions of the company’s most profitable antidepressant medication. The Office of Fair Trading in Britain has launched the investigation into the alleged payoffs by GSK to keep the sales of its drug Seroxat high. The alleged

read more

Headlines

Genocide Trial in Guatemalan Suspended Genocide Trial in Guatemalan Suspended
One Suspect in Boston Killed, one on the run One Suspect in Boston Killed, one on the run
Musharraf Flees as Bail is Revoked Musharraf Flees as Bail is Revoked
Some Say New Immigration Bill too Stringent Some Say New Immigration Bill too Stringent
read more

Sponsors