Dr Reddy's gets USFDA nod for doxorubicin hydrochloride liposome injection

Pharma major Dr. Reddy's Laboratories Ltd has received approval from the US Food and Drug Administration (USFDA) to launch doxorubicin hydrochloride liposome injection, for intravenous use, in the US market.

Dr Reddy's Laboratories (DRL) has received approval from the United States health regulator to sell its generic version of Alza Corporation's Doxil injection used for treatment of ovarian cancer. The Indian drug firm indicated that the approval after an extensive alliance with its partner on R&D and manufacturing capabilities.

Commenting on the regulatory approval, Dr.Reddy's EVP and Head of the North America Generics business, Alok Sonig, viewed, "It is a testament to our commitment to bring affordable generic medicines to market for patients".

The company revealed that Doxorubicin Hydrochloride Liposome Injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. "We are preparing for a commercial launch soon", he said. "This approval would not have been possible without their guidance and support", Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer, Natco Pharma, said.

The Doxil brand and generic had U.S. sales of approximately $196 million for the most recent twelve months ended in March 2017, according to IMS Health.

Shares of DRL were trading at Rs 2,743.20 apiece in the afternoon trade, up 0.74%, from the previous close on the BSE.

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