Moneycontrol Bureau
Sun Pharma Advanced Research Company (SPARC), the research subsidiary of Sun Pharmaceutical Industries, on Saturday has received a complete response letter (CRL) from the US Food and Drug Administration (USFDA) for its new drug application (NDA) for a preservative-free eye drop.
SPARC said it submitted a response to an earlier letter it had received from the USFDA, wherein no additional preclinical or clinical data was required for Xelpros, Latanoprost BAK-free eyedrops.
While the USFDA has accepted the clarifications and changes to the labeling, SPARC has now received another letter from the USFDA seeking minor changes to the proposed labeling, it added.
The research company is hopeful of addressing these requirements soon.
Latanoprost BAK-free is a Benzyalkonium Chloride-free, once-a-day formulation of the glaucoma medication Latanoprost using SPARC's novel swollen micelle microemulsion (SMM) technology. Unlike conventional glaucoma eyedrops, Latanoprost BAK-free does not cause or aggravate ocular surface disease (OSD).
This product is going to be manufactured at Sun Pharma's Halol facility in Gujarat that received a Form 483 from USFDA last year.
SAPRC said the 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. It had recently out-licensed this product to a subsidiary of Sun Pharmaceutical.
Sun Pharma Advanced Research Company (SPARC), the research subsidiary of Sun Pharmaceutical Industries, on Saturday has received a complete response letter (CRL) from the US Food and Drug Administration (USFDA) for its new drug application (NDA) for a preservative-free eye drop.
SPARC said it submitted a response to an earlier letter it had received from the USFDA, wherein no additional preclinical or clinical data was required for Xelpros, Latanoprost BAK-free eyedrops.
While the USFDA has accepted the clarifications and changes to the labeling, SPARC has now received another letter from the USFDA seeking minor changes to the proposed labeling, it added.
The research company is hopeful of addressing these requirements soon.
Latanoprost BAK-free is a Benzyalkonium Chloride-free, once-a-day formulation of the glaucoma medication Latanoprost using SPARC's novel swollen micelle microemulsion (SMM) technology. Unlike conventional glaucoma eyedrops, Latanoprost BAK-free does not cause or aggravate ocular surface disease (OSD).
This product is going to be manufactured at Sun Pharma's Halol facility in Gujarat that received a Form 483 from USFDA last year.
SAPRC said the 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. It had recently out-licensed this product to a subsidiary of Sun Pharmaceutical.
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