Dive Brief:
- In March, the FDA approved Elepsia (levetiracetam) XR, which was developed by Sun Pharma Advanced Research Company (SPARC).
- The FDA has revoked approval for Elepsia XR due to regulatory compliance issues at Sun Pharma's Halol Plant.
- SPARC received a complete response letter from the FDA earlier this month and has stated that it is working closely with the FDA to resolve all regulatory compliance issues.
Dive Insight:
As the FDA increases the number of international inspections, several times a month, there is news of another import alert or refusal of application; however, one of the strictest actions that the FDA can take in light of quality-related findings during an inspection is revocation of an approval. This revocation comes at a critical moment for SPARC, just as it was embarking on fund-raising, looking for co-marketing partners and overseeing launch details.
Unfortunately, the CRL comes at a time when Sun Pharma has come under fire for numerous quality-control and compliance issues, including adverse observations made during a plant audit in Halol last year. The upshot of this are continued disruptions in maintaining supply commitments, as well as increasing lack of trust in Sun Pharma and their products.