FDA revokes Sun Pharma's approval for epilepsy drug after compliance concerns
- 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.
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.
- The Business Standard US FDA revokes approval to Sun Pharma's anti epilepsy drug