Sun confirmed it had received a complete response letter on Friday, explaining that the decision reversed an approval granted by the agency to its research and development (R&D) division, Sun Pharma Advanced Research Company (SPARC), in March.
A Sun spokeswoman told us the revocation is “related to the compliance issues at the Halol plant at the time of approval for this product in March 2015.
She added that: “Sun Pharma has indicated that it is focused on resolving the issues and that its remediation process for Halol is on track.”
The drug – which is earmarked for launch in the US in the second half of 2016 according to a July business update – was the first SPARC drug approved by the US Food and Drug Administration (FDA).
The Sun spokeswoman told us “SPARC will continue to evaluate all options that help bringing this product to market faster.”
The US Food and Drug Administration (FDA) has a complex relationship with Sun’s Halol site.
In 2012, the agency temporarily allowed Sun to produce a generic version of the cancer drug Doxil (doxorubicin hydrochloride) at the site for the US market as a result of shortages caused by the problems at J&J's supplier Ben Venue.
Since then the FDA’s view of the Halol plant has been less positive.
Lats September agency inspectors found incomplete records during a surprise visit to the site, prompting Sun to begin implementing corrective measures.
The Elepsia XR approval was viewed as an indication these efforts were working although – as analysts pointed out during an earnings call last month – when the US FDA rejected Sun’s Xelpros (Latanoprost) in August it cited ongoing problems at the facility.