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Morphine Sulfate Oral Solution Approved

April 19, 2018

A PPM Brief

FDA has approved ANI Pharmaceuticals (Baudette, MN) ANDA for morphine sulfate oral solution. At 10mg/5mL, 20mg/5mL and 100mg/5mL, the medication is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The oral solution at 100 mg per 5 mL (20 mg/mL) is specifically indicated for the relief of acute and chronic pain in opioid-tolerant patients.

"We are pleased to announce the approval of this internally developed generic product, which leverages both our liquid manufacturing and controlled substance capabilities. In addition to the standard packaging formats, we intend to launch the product in a unit dose configuration," said ANI President and CEO Arthur S. Przybyl, in a company press release. The manufacturer expects to begin shipping product to its customers in the near future, according to the release.




Last updated on: April 19, 2018
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