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GSK no longer will seek approval for Avodart
LONDON — GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.
The drug maker announced it no longer would pursue global approval for Avodart (dutasteride) and would work with regulatory agencies to remove the indication from the product’s license.
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FDA extends NDA review for Novartis' COPD treatment
BASEL, Switzerland — The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.