FDA approves 2 Amneal generics

10/19/2018
Amneal Pharmaceuticals has received clearance from the Food and Drug Administration for a generic version of Isuprel injection (isoproterenol hydrochloride) in 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) single-dose vials.

"We are pleased to add isoproterenol to our portfolio of injectable products," Amneal’s executive vice president of commercial operations Andy Boyer said in a statement. "With four injectable product launches this year, we have quickly expanded our portfolio to 12 products. Our pipeline contains additional opportunities that will further enhance this important segment of our business."

Isoproterenol hydrochloride injection had a market value of about $158 million for the 12 months ended August 2018, according to IQVIA data.

Amneal also has received FDA approval for a generic version of BiCNU (carmustine) for injection, 100 mg.

Carmustine for injection had a market value of about $84 million for the 12 months ended August 2018, according to IQVIA data.
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