Amneal Resumes Shipping of Axid® Equivalent Nizatidine Oral Solution

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today 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. Click here for full prescribing information.

Indications and Usage In adult patients, nizatidine is indicated for:

• Up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.

• Maintenance therapy for duodenal ulcer patients at a dosage of 150 mg/daily at bedtime after healing of an active duodenal ulcer.

• Up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.

• Up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.

In pediatric patients ages 12 years and older, nizatidine oral solution is indicated for:

• Up to 8 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.

Important Safety Information

Contraindication Nizatidine oral solution is contraindicated in patients with known hypersensitivity to the drug or with a history of hypersensitivity to other H2-receptor antagonists.

Precautions Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy. Because nizatidine is excreted primarily by the kidney, dosage should be reduced in patients with moderate to severe renal insufficiency. Adverse Reactions (adult) In placebo-controlled trials, anemia (0.2% vs 0%) and urticaria (0.5% vs 0.1%) were significantly more common in the nizatidine group compared to the placebo group.

The only adverse event that occurred in >10% of patients receiving nizatidine was headache. Adverse events that occurred in 3% to 10% of patients were pain, asthenia, diarrhea, dizziness, insomnia, rhinitis, and pharyngitis.

Adverse Reactions (pediatric)

In controlled clinical trials in pediatric patients (aged 2 to 18 years), adverse experiences that occurred in >5% of patients were pyrexia, nasopharyngitis, diarrhea, vomiting, irritability, nasal congestion, and cough. Most adverse events were mild or moderate in severity. Mild elevations in serum transaminase (1 to 2 ULN) were noted in some patients. Adverse reactions reported for nizatidine may also occur with nizatidine oral solution.

Use in Specific Populations Pregnancy and Nursing Mothers: Only use nizatidine during pregnancy and while nursing if it is clearly needed.

Pediatric Use: Effectiveness in pediatric patients <12 years of age has not been established.

Geriatric Use: Differences in responses between the elderly and younger patients have not been identified, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients are more likely to have decreased renal function. Select doses carefully and consider monitoring renal function.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.

SOURCE: Amneal Pharmaceuticals, Inc