USFDA reject approval of Sun Pharma’s novel anti-glaucoma eye drops
USFDA rejected Sun Pharma Advanced Research Company’s Application for its new anti-glaucoma eye drops. The product is to be manufactured at Sun Pharmaceutical Industries’ Halol facility. USFDA has indicated that a satisfactory resolution of the current good manufacturing practice (cGMP) deficiencies at this facility is a prerequisite for the final approval of Xelpros.
“The US Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its new drug application (NDA) for Xelpros, Latanoprost BAK-free eyedrops,” SPARC Ltd said in a statement.
Latanoprost BAK-free is a preservative-free, once-a-day formulation of the glaucoma medication using Swollen Micelle Microemulsion (SMM) technology. Unlike conventional glaucoma eyedrops, Latanoprost BAK-free does not cause or aggravate Ocular Surface Disease (OSD).
“While the USFDA has accepted the clarifications and changes to the labeling, SPARC has now received another CRL from the USFDA seeking minor changes to the proposed labeling. SPARC hopes to address these requirements soon,” it added.