The Priority Review

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Zydus Pharmaceuticals

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  1. Approvals

    FDA approves once-weekly generic hormone therapy patch for women

    The FDA approved the first generic of Climara Pro, a transdermal estradiol and levonorgestrel system (0.045 mg per day/0.015 mg) applied once a week for women with an intact uterus. The generic is therapeutically equivalent to Climara Pro and the most common adverse reactions are application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome (≥5 %).