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Sandoz gets FDA nod for Altavera
PRINCETON, N.J. — The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.
Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Altavera (levonorgestrel and ethinyl estradiol) tablets, a generic version of Duramed’s Nordette.
Branded and generic versions of Nordette had sales of about $57.4 million during the 12-month period ended in February, according to IMS Health.
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Hi-Tech granted tentative approval for generic Levaquin
AMITYVILLE, N.Y. — The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.
Hi-Tech announced the tentative approval of levofloxacin oral solution in the 25 mg-per-mL strength. The drug is used to treat mild, moderate and severe bacterial infections in adults.