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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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Sunovion Pharmaceuticals announces availability of Aptiom
MARLBOROUGH, Mass. — Sunovion Pharmaceuticals on Monday announced that Aptiom (eslicarbazepine acetate), a once-daily antiepileptic drug, is now available across the United States.
The drug, which received approval from the Food and Drug Administration on Nov. 8, 2013, is a prescription medicine used with other medicines to treat partial-onset seizures. The drug is available in four table strengths: 200 mg, 400 mg, 600 mg and 800 mg; it can be taken whole or crushed, with food or without.