Amneal receives FDA blessing for 4 generics
Amneal has received the Food and Drug Administration’s green light for four generic injectables products: dexamethasone sodium phosphate injection, 10 mg/mL, azacitidine 100 mg, carboprost tromethamine injection, 250 mcg/mL and atropine sulfate injection, 0.5 mg/5 mL.
Dexamethasone and azacitidine are both currently on the FDA drug shortage list, and atroprine was granted Competitive Generic Therapy status by the FDA, the company said.
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“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,” Chirag and Chintu Patel, Amneal co-CEOs, said.
“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,” Harsher Singh, senior vice president of Amneal Biosciences, said.
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Dexamethasone is a generic of dexamethasone sodium phosphate injection. The medication has a market value of $66 million for the 12 months ended December 2021, according to IQVIA.
Azactidine is the generic of Vidaza. The product has a market value of $61 million for the 12 months ended December 2021, according to IQVIA.
Carboprost is a generic of the prostaglandin Hemabate. The market value of this medication is $57 million for the 12 months ended December 2021, according to IQVIA.
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Atropine is a generic of atropine sulfate injection. The drug has a market value of $1 million for the 12 months ended December 2021, according to IQVIA.