Teva Pharmaceutical Industries Ltd, announced the launch of an authorized generic of Cubicin (daptomycin for injection) 500 mg per vial in the United States.

Daptomycin for injection is an antibacterial drug indicated in adults for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

Daptomycin for injection is indicated in adults for the treatment of Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.

Daptomycin for injection is not indicated for the treatment of pneumonia. Daptomycin for injection is not indicated for the treatment of left-sided infective endocarditis (LIE) due to S. aureus. Daptomycin for injection has not been studied in patients with prosthetic valve endocarditis.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of daptomycin for injection and other antibacterial drugs, daptomycin for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, it should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Empiric therapy may be initiated while awaiting test results.

Teva remains committed to strengthening its generic injectable business globally with continued investment in newer, higher-value generic injectable products. Teva currently has 338 product registrations pending FDA approval and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the US. Currently, 1-in-5 generic prescriptions dispensed in the US is filled with a Teva generic product.

Daptomycin for injection had annual sales of approximately $1.2 billion in the United States, according to IMS data as of July 2016.