Amneal and Shilpa Announce U.S. FDA Approval of BORUZU™, the First Ready-to-Use Version of Bortezomib for subcutaneous administration

Represents Amneal’s fourth 505(b)(2) injectable approval in 2024

Ready-to-use oncology treatment used for multiple myeloma and mantle cell lymphoma

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) and Shilpa Medicare Limited (“Shilpa”) announced U.S. Food and Drug Administration (FDA) approval of BORUZU^™, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration.

BORUZU (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade^®, a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU is expected to launch with a unique J-code in the second quarter of 2025.

“We are building a distinct branded oncology injectable portfolio. The approval of BORUZU is our fourth 505(b)(2) injectable approval this year. These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians. We look forward to bringing more branded oncology products to the market for providers while expanding access for patients,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology.

“This second NDA approval in the US market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce pharmacy efficient solutions that enhance preparation and have the potential to reduce patient wait times. This development exemplifies Shilpa’s constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool,” said Vishnukant Bhutada, Managing Director of Shilpa Medicare.

The most commonly reported adverse reactions for BORUZU in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia. For full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for bortezomib for the 12 months ended December 2023 were approximately $96 million.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

About Shilpa

Shilpa Medicare is a specialized API and formulations focused pharmaceuticals company. Founded in 1987, India-based Shilpa develops, manufactures and markets active pharmaceutical ingredients (APIs) and formulations for generic medications across Oncology and other therapeutic areas. Further to consolidation in the field of oncology API and formulations, we are striving to put in our efforts in the field of novel drug delivery systems and biotech products along with widening our focus to other therapy areas. For more information, please visit www.vbshilpa.com.

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