FDA Gives Then Rescinds Clearance For Aurobindo Plant
Shares Plunge As FDA Says Investigation Into Unit IV ‘Still Open’
Aurobindo Pharma shares have nosedived after the US Food and Drug Administration said an investigation into one of the Indian drugmaker’s plants was still open, days after issuing a notice giving the site the all-clear.
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Sandoz US president Carol Lynch talked to Scrip about its changing US portfolio, which will emphasize biosimilars, as the Novartis unit is poised to divest most of its US generics portfolio to Aurobindo.
Sandoz says it expects to close the sale of its US dermatology and oral solids business to Aurobindo by the end of the first quarter of 2020, having seen the deal’s completion date pushed back from 2019.
Aurobindo believes it has “substantially addressed” all requirements for an FTC go-ahead for its acquisition of Sandoz’s US dermatology and generic oral solids businesses. The integration of the acquired Apotex business in Europe is also shaping up.