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Teva’s generic Vagifem launches

JERUSALEM — Teva on Monday announced the launch of its generic Vagifem (estradiol vaginal inserts). The drug is indicated to treat atrophic vaginitis due to menopause.

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FDA chief promises ANDA submission guidance by year’s end

At a public meeting on July 18, Food and Drug Administration commissioner Scott Gottlieb said that by the end of the year, the agency would develop an internal strategy for dealing with abbreviated new drug applications, as well as a guidance on the best submission practices.