Catalyst

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The concerns raised by the FDA in a CRL letter pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA

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Additional Information

Additional Relevant Details No Safety or Efficacy Concerns or Additional Clinical Trials Identified for Approval of Latanoprostene BunodFDA Letter Related to CGMP at Bausch + Lomb Facility
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Catalyst Date
Occurred on:
Jul 22, 2016
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Related Keywords Crl