US FDA has rescinded the 90-day VAI letter to Aurobindo

In a surprise turn of events, the US Food and Drug Administration has rescinded the 90-day VAI (voluntary action indicated) letter that was issued to Indian drugmaker Aurobindo's (BSE: 524804) Unit IV facility. This is probably the first time the regulator has taken any such action.

The action implies that the inspection conducted by the US FDA at Unit IV in November 2019 is still open and under review.

Unit IV is a key facility for Aurobindo and houses its injectable and ophthalmic filings (46 pending approvals and 30% of overall filings). Injectables have been a key growth driver for the company and has contributed almost 18% of its US revenues in the first nine months of fiscal year 2019/20.