Amneal Pharmaceuticals announced the approval of four generic injectables products. Dexamethasone sodium phosphate injection, USP 10 mg/mL, azacitidine 100 mg, carboprost tromethamine injection, USP 250 mcg/mL, and atropine sulfate injection, USP 0.5 mg/5 mL, have received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA). Dexamethasone and azacitidine are both currently on the FDA drug shortage list, and atroprine was granted Competitive Generic Therapy (CGT) status by the FDA.
The Company has approximately 25 commercial injectables for the U.S. institutional market and is targeting over 40 launches from 2021 to 2025 in a variety of complex areas, such as drug/device combinations, peptides, long acting injectables and large volume parenteral (LVP) bags.
“An important element of Amneal’s long-term growth strategy is expanding our injectables business, and today’s announcement of four new approvals is another key step. We look to scale our injectables business through new products and by leveraging our recent Puniska and Saol baclofen franchise acquisitions towards our goal of being top five in the U.S. institutional injectables market and a global player over time,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “These four approvals, including two products currently on the FDA drug shortage list, demonstrate our commitment to the institutional market and to alleviating drug shortages so that patients can have access to the medicines they need,” said Harsher Singh, SVP for Amneal Biosciences.
Dexamethasone is a bioequivalent and therapeutically equivalent generic to the reference standard dexamethasone sodium phosphate injection, USP 10 mg/mL. This corticosteroid is currently on the FDA drug shortage list. According to IQVIA®, U.S. annual sales for dexamethasone injection for the 12 months ended December 2021 were $66 million.
Azactidine is the generic equivalent for Vidaza® Injection 100 mg. This antineoplastic drug is currently on the FDA drug shortage list. According to IQVIA®, U.S. annual sales for azacitidine injection for the 12 months ended December 2021 were $61 million.
Carboprost is a generic version of the prostaglandin Hemabate® Injection, 250 mcg/mL. According to IQVIA®, U.S. annual sales for this product for the 12 months ended December 2021 were $57 million.
Atropine is an anticholinergic agent. It is a bioequivalent and therapeutically equivalent generic to the reference listed drug atropine sulfate injection, USP, 0.5 mg/5 mL in a pre-filled single-dose syringe. This product was granted CGT status. According to IQVIA®, U.S. annual sales for this product for the 12 months ended December 2021 were $1 million.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!