Dr.Reddy’s Laboratories Ltd (ADR) (NYSE:RDY) disclose that it received FDA approval for introducing Doxorubicin Hydrochloride Liposome Injection in the United States. The company revealed that this is a therapeutic equivalent generic type of Doxil for intravenous use in the American market. The Indian drug firm indicated that the approval after an extensive alliance with its partner on R&D and manufacturing capabilities.
Dr.Reddy’s believes that the approval represented the first of its kind in the complex depot injectables arena. The company pointed out that the Doxil brand, as well as, generic generated sales of about $196 million MAT for the recent twelve-month period ended March 2017 in the United States. This was based on the data of IMS Health.
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 approval further validates our capabilities to successfully develop and manufacture complex liposomal formulations. We are preparing for a commercial launch soon.”
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. Every 10-mL vial includes 20 mg doxorubicin hydrochloride at a concentration of 2 mg/mL.
Following the news, the stock is gaining 0.90 percent in pre-market on Wednesday.