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Teva receives FDA approval for generic Lovaza
JERUSALEM — Teva Pharmaceutical Industries announced that it has received approval from the Food and Drug Administration for its generic form of Lovaza (omega-3-acid ethyl esters capsules, USP) in the United States.
Lovaza is used as an adjunct to diet to reduce triglycerdide levels in adult patients, according to the FDA. Teva believes it is the first to file and plans to begin shipping immediately.
Lovaza capsules, marketed by GlaxoSmithKline, had annual sales of $1.1 billion in the United States as of December 2013, according to IMS data.
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Boehringer Ingelheim gets FDA nod for Pradaxa
RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals announced that the Food and Drug Administration has approved Pradaxa (dabigatran etexilate mesylate). The drug is indicated for the treatment of deep venous thrombosis and pulmonary embolism in patients who have received a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated, the company said.