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ANI Pharma Announces Approval Of Morphine Sulfate Oral Solution

ANI Pharmaceuticals Inc. (ANIP) said that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application or "ANDA" for Morphine Sulfate Oral Solution 10mg/5mL, 20mg/5mL and 100mg/5mL. The current annual U.S. market for this product is approximately $17 million, according to Iqvia/IMS Health. ANI expects to begin shipping product to its customers in the near future.

Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant patients.

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