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Sun Pharma In The News

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Sun Pharma gets FDA nod for cancer drug

Product is first generic version of Doxil, which was approved in 1995 to treat ovarian cancer

Sun Phar­maceutical Industries has received approval from the US food and drug adminis­tration (USFDA) to sell generic version of Doxil, a scarce anti-cancer drug

Doxil's chemical name doxorubicin hydrochloride liposome injection is cur­rently on the USFDA's drug shortage list. This medicine approval is expected to fur­ther boost export earnings of Sun Pharma, which has significant presence in the US. United States is the world's largest drug market.

Doxorubicin HC1 lipo­some injection is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.

For products on the shortage list, the FDA's of­fice of generic drugs is using a priority review sys­tem to expedite the review of generic applications to help alleviate shortages.

"This generic Doxoru­bicin HC1 Liposome injec­tion USR 2 mg/mL is thera-peutically equivalent to Doxil Liposome injection, 2 mg/mL of Janssen Re­search and Development," said a company statement.

Doxil or Doxorubicin HC1 Liposome Injection is pack­aged in 20 mg/lOmL and 50 mg/25mL single-use vials. Doxorubicin hydrochloride liposome injection is admin­istered intravenously by a health care professional.

Sun Pharma's foreign subsidiary Israel based Taro, posted a 26 per cent increase in net profit for the October-December quarter. Taro's net profit rose to $87 million

from $69 million in the cor­responding year-earlier peri­od. Sales grew 25.4 per cent to $ 186 million boosted by an increase in prices of some products in the US.

Sun Pharma holds a 66 per cent stake in Taro and contributed about 32 per cent of Sun Pharma's rev­enue in financial year 2012. Sun Pharma will an­nounce its third quarter re­sult on Friday. Reuters adds: Sun's prod­uct is the first generic ver­sion of Doxil, which was ap­proved in 1995 and is used to treat ovarian cancer, AIDS-related Kaposi's sar­coma, and multiple myelo­ma. Doxil is made by Johnson &Johnson.

Doxil fell into short sup­ply after manufacturing problems at an outside con­tract manufacturer, Ben Venue Laboratories, a unit of German drugmaker Boehringer Ingelheim, sus­pended operations in No­vember 2011 due to quality control problems.

Last February, the FDA allowed for the temporary importation of Lipodox, which is made by Sun and contains the same active in­gredient as Doxil. The agency said it intends to con­tinue allowing the importa­tion of Lipodox until Sun has made enough generic Doxil to meet demand.

Late last month a federal judge approved a consent decree under which Ben Venue must bring its Bed­ford, Ohio facility into com­pliance with regulatory re­quirements or face fines and other penalties. The FDA said the company had re­peatedly violated good man­ufacturing practices. Recent inspections found that poor­ly maintained equipment deteriorated to the point that it shed particles into injectable drugs, the FDA said.