‘Voluntary Action Initiated’ Revoked by U.S. FDA for Aurobindo Pharma Unit
Uncertainty and anxiety among investors as the FDA for the first time in recent years reversed its own decision.Â
The US Food and Drug Administrator (USFDA), days after its missive to Aurobindo Pharma Ltd, revoked the Voluntary Action Initiated (VIA), stating that the investigation is incomplete and is still ongoing. Uncertainty and anxiety among investors occur, as the FDA for the first time in recent years reversed its own decision.
On Friday, Aurobindo said in a disclosure with the bourses, ” From November 4, 2019, to November 13, 2019, the inspection conducted by the USFDA at our aforesaid unit IV, is still open and under review by way of rescindment of 90-day VAl letter that was issued by them on February 18, 2020.”
For the company’s key injectable plant unit 4, at Pashamylaram, Hyderabad, the city-based generic drugmaker said the FDA issued an Establishment Inspection Report with VAI on Wednesday. Aurobindo’s shares surged 19 percent to Rs 594 on BSE in early trade following the announcement.
Between November 4 and 13, 2019, the inspection was conducted
. With 14 observations, the regulator had issued a ‘Form 483’, at the end of the inspection. None of the observations were related to data integrity issues said the firm subsequently. Unit 4 has 15 abbreviated new drug applications (ANDA) approvals pending currently.However, a fresh missive stating that the investigation was ‘still open and under review’ was sent by the FDA on Friday.
Many investors faced anxiety and uncertainty as this perhaps is the first time in recent years that the regulator, the US Food and Drug Administrator (USFDA), after inspecting, reversed its own decision regarding the Aurobindo Pharma Unit.
‘Voluntary Action Initiated’ Revoked by U.S. FDA for the Aurobindo Pharma unit. US FDA revokes the ‘Voluntary Action Initiated’ status for Aurobindo Pharma’s unit. ‘Voluntary Action Initiated’ Revoked by U.S. FDA for Aurobindo Pharma unit – Source
