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Teva Launch Authorized Generic of Cubicin in the United States

 

 

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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.

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 U.S. Currently, 1-in-5 generic prescriptions dispensed in the U.S. 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.

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