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FDA Science, Research, and Collaboration Advance Generic Medicines

In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product quality and performance. ....

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SN BioScience and Boryung Announce the Licensing Agreement on Generic Version of Abraxane

/PRNewswire/ SN BioScience (CEO Park Young-hwan) and Boryeong (CEO Jang Doo-hyun) signed a domestic manufacturing technology transfer and co-development. ....

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US Executive Branch Update – March 16, 2022 - Government, Public Sector

This report provides a snapshot of the US Executive Branch priorities via daily schedules and the prior day's press releases. ....

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US Executive Branch Update – February 4, 2022 - Government, Public Sector

This report provides a snapshot of the US Executive Branch priorities via daily schedules and the prior day's press releases. ....

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Zydus Cadila announces USFDA approval for First Generic for Ibrutinib Capsules, 70 mg and gets eligibility for 180-day exclusivity

Zydus Cadila announces USFDA approval for First Generic for Ibrutinib Capsules, 70 mg and gets eligibility for 180-day exclusivity
Posted On:
2021-04-07 21:49:22
(Time Zone: Arizona, USA)
Zydus Cadila has received final approval from the USFDA to market Ibrutinib Capsules, 70 mg and 140 mg (US RLD: Imbruvica Capsules). Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom s macroglobulinemia.
According to the USFDA letter, Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg. Therefore, with this approval, Zydus is eligible for 180 days of generic drug exclusivity for Ibrutinib Capsules, 70 mg. For Ibrutinib Capsules, 140 mg, the company will have 180-days of shared generic drug exclusivity. The 7 ....

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