Granules India files Paragraph IV certification for Ruxolitinib ER tablets

Hyderabad, Oct 7 (UNI) Granules India Ltd on Wednesday announced that it has submitted a Paragraph IV certification in connection with its abbreviated new drug application (ANDA) for Ruxolitinib Extended-Release Tablets, and believes it may be eligible for first-to-file status in the US, subject to review and determination by the US Food and Drug Administration (FDA). In a release, the Hyderabad based company said it has provided the required notice to the relevant parties in accordance with applicable US regulatory requirements. Based on the timing and status of its ANDA and Paragraph IV certification, Granules India believes it is eligible…