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Dr Reddy's gets greenlight to market Doxil generic

Published on 18/05/17 at 11:19am

Dr Reddy’s Laboratories, one of India’s largest pharmaceutical firms, has revealed that the FDA has given the go-ahead to market its doxorubicin hydrochloride liposome injection in the US. The product is a generic version of Johnson & Johnson’s Doxil, a chemotherapy drug used in the treatment of ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma.

The approved injectable is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. The FDA’s decision is the culmination of a collaborative R&D and manufacturing partnership between Dr Reddy’s and Natco Pharma. "We are pleased with our partnership with Dr Reddy's Laboratories. The approval would not have been possible without their guidance and support," commented Natco Vice-Chairman and CEO Rajiv Nannapaneni.

Alok Sonig, executive vice-president and head of the North America generics business at Dr Reddy's, celebrated the news by stating: "This approval represents the first of its kind for Dr Reddy's in the complex depot injectables arena. The approval further validates our capabilities to successfully develop and manufacture complex liposomal formulations. We are preparing for a commercial launch soon."

Dr Reddy’s will be hoping to take a slice of Doxil’s market share, which generated around $196 million throughout the year as of March.

Matt Fellows

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