The US Food and Drug Administration has refused approval to Sun Pharma Advanced Research Company (SPARC) application for anti-glaucoma eyedrop citing non-satisfactory practice of good manufacturing procedures.
The proposed manufacturing site at Sun Pharmaceutical Industries’ Halol facility lack prerequisites for the approval of the drug called Xelpros, said company in a statement.
“The U.S. 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 said. The CRL has informed the company that the drug cannot be approved in its current form.
The drug was developed by SPARC and given out on franchise to its subsidiary based on a CRL given by the USFDA. With the refusal now, citing no additional pre-clinical or clinical data, the company is back to square one to begin the clinical stage again to get the approval.
“While the USFDA has accepted the clarifications and changes to the labelling, SPARC has now received another CRL from the USFDA seeking minor changes to the proposed labelling. SPARC hopes to address these requirements soon,” it added.
Unlike conventional glaucoma eyedrops, Latanoprost BAK-free is a preservative-free, once-a-day formulation with Swollen Micelle Microemulsion (SMM) technology. Being Latanoprost BAK-free, it does not cause or aggravate Ocular Surface Disease (OSD), said the company.
Last year, Sun Pharmaceuticals faced ban from the USFDA for its cephalosporin facility located at Karkhadi in Gujarat, for non-compliance of good manufacturing practice, along with other Indian pharma companies such as Ranbaxy Laboratories and Wockhardt.
As on March, 2013, Sun Pharma had 12 US FDA facilities, with six in the U.S., three in India and one in Canada, Israel and Hungary, respectively. The company caters to the U.S. markets, which contribute around 54% of its sales (2012-13). Also, its subsidiaries of the likes of Taro, Caraco and the recent acquisitions contribute a major chunk of the sales and growth