Granules India files Paragraph IV certification for Ruxolitinib ER tablets

Hyderabad, Oct 7 (TNT): 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, potentially making it eligible for first-to-file status in the US, subject to review and determination by the US Food and Drug Administration (FDA).

It has provided the required notice to the relevant parties in accordance with applicable US regulatory requirements, the Hyderabad based pharma company said in a release..

Based on the timing and status of its ANDA and Paragraph IV certification, Granules India believes it may be eligible for first-to-file status for the product.

If confirmed by the FDA and subject to applicable statutory and regulatory requirements, the status could provide eligibility for 180 days of generic drug exclusivity under US law.

The company clarified that the ANDA remains under FDA review and that the announcement should not be construed as FDA approval of the product or confirmation of first-to-file status or exclusivity by the regulator.

Granules India Chairman and Managing Director Dr Krishna Prasad Chigurupati said first-to-file opportunities were an important part of the company’s strategy to build a more differentiated and higher-value product portfolio in the US.

He said the filing reflected the company’s focus on identifying technically and commercially attractive opportunities where its development and manufacturing capabilities could create sustainable value.

The company said it would provide further updates, as appropriate, in accordance with applicable disclosure requirements.

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