Generics
ANI Pharmaceuticals awarded US FDA's approval for generic Morphine Sulfate Oral Solution
19 April 2018 -

Pharmaceutical company ANI Pharmaceuticals Inc (Nasdaq:ANIP) revealed on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Morphine Sulfate Oral Solution in 10mg/5ml, 20mg/5ml and 100mg/5ml.

Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic. The 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, added the company.

Annually, the current US market for Morphine Sulfate Oral Solution is about USD17m, according to Iqvia/IMS Health.

In conjunction with the approval, the company expects to begin shipping Morphine Sulfate Oral Solution to its customers in the near future.

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