BRIDGEWATER, N.J. — Amneal Pharmaceuticals announced that its nizatidine oral solution 15 mg/mL (75 mg/5 mL) is now available for reorder. The drug, the generic equivalent of Axid, is the only oral liquid form of nizatidine available in the US. The Amneal product meets all FDA requirements and specification limits related to NDMA.
“Nizatidine has been a trusted active ingredient for over 30 years,” said Joe Todisco, executive vice president, chief commercial officer for the Amneal Specialty Division that distributes the product. “Patients, prescribers and pharmacists have seen their treatment options dwindle, which is why we are so pleased to bring the oral liquid formulation back to market.”
Nizatidine oral solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). Nizatidine oral solution is contraindicated in patients with known hypersensitivity to the drug or with a history of hypersensitivity to other H2- receptor antagonists. The Amneal product is available as a peppermint-flavored liquid sold in 480 mL bottles.