FDA approves ANI’s morphine sulfate oral solution
The Food and Drug Administration has approved ANI Pharmaceuticals’ morphine sulfate oral solution, 10 mg/5 ml, 20 mg/5 ml and 100 mg/5 ml. The Baudette, Minn.-based company’s generic is indicated to manage acute and chronic pain severe enough to require an opioid analgesic for which alternative treatments are inadequate.
ANI executives said that this approval marks the sixth that the company has received for a product from its internally developed pipeline. The company said it expects to ship the product — whose annual market size QVIA data pegs at around $17 million — in the near future.
“We are pleased to announce the approval of this internally developed generic product, which leverages both our liquid manufacturing and controlled substance capabilities,” ANI president and CEO Arthur Przybyl said. “In addition to the standard packaging formats, we intend to launch the product in a unit dose configuration.”
ANI executives said that this approval marks the sixth that the company has received for a product from its internally developed pipeline. The company said it expects to ship the product — whose annual market size QVIA data pegs at around $17 million — in the near future.
“We are pleased to announce the approval of this internally developed generic product, which leverages both our liquid manufacturing and controlled substance capabilities,” ANI president and CEO Arthur Przybyl said. “In addition to the standard packaging formats, we intend to launch the product in a unit dose configuration.”