HYDERABAD: Days after its missive to Aurobindo Pharma Ltd, the US Food and Drug Administrator (USFDA) revoked the Voluntary Action Initiated (VIA), saying the investigation was still ongoing and incomplete. This is perhaps the first time in recent years that the drugs regulator has reversed its own decision, causing anxiety and uncertainty among investors.
“The company received a communication that the inspection conducted by the USFDA at our aforesaid unit IV, from November 4, 2019 to November 13, 2019 is still open and under review by way of rescindment of 90-day VAl letter that was issued by them on February 18, 2020,” Aurobindo said on Friday in a disclosure with the bourses.
On Wednesday, the city-based generic drugmaker said the FDA issued an Establishment Inspection Report with VAI for its key injectable plant unit 4 at Pashamylaram, Hyderabad. Following the announcement, shares of Aurobindo surged 19 per cent to Rs 594 on BSE in early trade on Wednesday.
The inspection was conducted between November 4 and 13, 2019. At the end of the inspection, the regulator had issued a ‘Form 483’ with 14 observations. Subsequently, the firm said none of the observations were related to data integrity issues. Currently, unit 4 has 15 abbreviated new drug applications (ANDA) approvals pending.
However, on Friday, the FDA sent a fresh missive stating that the investigation was ‘still open and under review.’
FDA issued ‘Form 483’ with 14 observations
The inspection was conducted between November 4 and 13 last year. At the end of this inspection, the drugs regulator had issued a document ‘Form 483’ along with fourteen observations