SUPN - Supernus Pharma whiffs for now on NDAs for SPN-812 SPN-830

Supernus Pharmaceuticals (SUPN) says it received a complete response letter regarding its new drug application for SPN-812 for the treatment of ADHD in pediatric patients 6-17 years old.The FDA says the application is not ready for approval in its present form, citing Superna's in-house laboratory that conducts analytical testing, which recently moved to a new location; no clinical safety or efficacy issues were identified.Superna says it will discuss with the FDA that the application does not rely solely on this facility for product release, and will discuss steps required to re-submit the NDA for SPN-812.The company also received a refusal to file letter from the FDA regarding its NDA for SPN-830 for the continuous treatment of motor fluctuations in Parkinson's disease, as the agency requested certain documents and reports in support of the application.The company also raised its operating income forecast for the full year, now guiding for $155M-$170M compared

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Supernus Pharma whiffs for now on NDAs for SPN-812, SPN-830