FDA label 1197a605-9f66-43f5-84d9-5d580afd8aa4

5 WARNINGS AND PRECAUTIONS 5.1 Gastric Malignancy Symptomatic response with KAPIDEX does not preclude the presence of gastric malignancy.

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience The safety of KAPIDEX was evaluated in 4548 patients in controlled and uncontrolled clinical studies, including 863 patients treated for at least 6 months and 203 patients treated for one year. Patients ranged in age from 18 to 90 years (median age 48 years), with 54% female, 85% Caucasian, 8% Black, 4% Asian, and 3% other races. Six randomized controlled clinical trials were conducted for the treatment of EE, maintenance of healed EE, and symptomatic GERD, which included 896 patients on placebo, 455 patients on KAPIDEX 30 mg, 2218 patients on KAPIDEX 60 mg, and 1363 patients on lansoprazole 30 mg once daily. As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most Commonly Reported Adverse Reactions The most common adverse reactions (≥2%) that occurred at a higher incidence for KAPIDEX than placebo in the controlled studies are presented in Table 2. Table 2: Incidence of Treatment-Emergent Adverse Reactions in Controlled Studies Placebo KAPIDEX 30 mg KAPIDEX 60 mg KAPIDEX Total Lansoprazole 30 mg Adverse Reaction (N=896) % (N=455) % (N=2218) % (N=2621) % (N=1363) % Diarrhea 2.9 5.1 4.7 4.8 3.2 Abdominal Pain 3.5 3.5 4.0 4.0 2.6 Nausea 2.6 3.3 2.8 2.9 1.8 Upper Respiratory Tract Infection 0.8 2.9 1.7 1.9 0.8 Vomiting 0.8 2.2 1.4 1.6 1.1 Flatulence 0.6 2.6 1.4 1.6 1.2 Adverse Reactions Resulting in Discontinuation In controlled clinical studies, the most common adverse reaction leading to discontinuation from KAPIDEX therapy was diarrhea (0.7%). Other Adverse Reactions Other adverse reactions that were reported in controlled studies at an incidence of less than 2% are listed below by body system: Blood and Lymphatic System Disorders: anemia, lymphadenopathy Cardiac Disorders: angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitation, tachycardia Ear and Labyrinth Disorders: ear pain, tinnitus, vertigo Endocrine Disorders: goiter Eye Disorders: eye irritation, eye swelling Gastrointestinal Disorders: abdominal discomfort, abdominal tenderness, abnormal feces, anal discomfort, Barrett's esophagus, bezoar, bowel sounds abnormal, breath odor, colitis microscopic, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hypermotility disorders, GERD, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irritable bowel syndrome, mucus stools, nausea and vomiting, oral mucosal blistering, painful defecation, proctitis, paresthesia oral, rectal hemorrhage General Disorders and Administration Site Conditions: adverse drug reaction, asthenia, chest pain, chills, feeling abnormal, inflammation, mucosal inflammation, nodule, pain, pyrexia Hepatobiliary Disorders: biliary colic, cholelithiasis, hepatomegaly Immune System Disorders: hypersensitivity Infections and Infestations: candida infections, influenza, nasopharyngitis, oral herpes, pharyngitis, sinusitis, viral infection, vulvo-vaginal infection Injury, Poisoning and Procedural Complications: falls, fractures, joint sprains, overdose, procedural pain, sunburn Laboratory Investigations: ALP increased, ALT increased, AST increased, bilirubin decreased/increased, blood creatinine increased, blood gastrin increased, blood glucose increased, blood potassium increased, liver function test abnormal, platelet count decreased, total protein increased, weight increase Metabolism and Nutrition Disorders: appetite changes, hypercalcemia, hypokalemia Musculoskeletal and Connective Tissue Disorders: arthralgia, arthritis, muscle cramps, musculoskeletal pain, myalgia Nervous System Disorders: altered taste, convulsion, dizziness, headaches, migraine, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia Psychiatric Disorders: abnormal dreams, anxiety, depression, insomnia, libido changes Renal and Urinary Disorders: dysuria, micturition urgency Reproductive System and Breast Disorders: dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder Respiratory, Thoracic and Mediastinal Disorders: aspiration, asthma, bronchitis, cough, dyspnoea, hiccups, hyperventilation, respiratory tract congestion, sore throat Skin and Subcutaneous Tissue Disorders: acne, dermatitis, erythema, pruritis, rash, skin lesion, urticaria Vascular Disorders: deep vein thrombosis, hot flush, hypertension Additional adverse reactions that were reported in a long-term uncontrolled study and were considered related to KAPIDEX by the treating physician included: anaphylaxis, auditory hallucination, B-cell lymphoma, central obesity, cholecystitis acute, decreased hemoglobin, dehydration, diabetes mellitus, dysphonia, epistaxis, folliculitis, gastrointestinal pain, gout, herpes zoster, hyperglycemia, hyperlipidemia, hypothyroidism, increased neutrophils, MCHC decrease, neutropenia, oral soft tissue disorder, rectal tenesmus, restless legs syndrome, somnolence, thrombocythemia, tonsillitis. Other adverse reactions not observed with KAPIDEX, but occurring with the racemate lansoprazole can be found in the lansoprazole package insert, ADVERSE REACTIONS section.

<table width="100%" ID="i991c099f-88b2-40e0-8a7d-bba502c13476"> <caption>Table 2: Incidence of Treatment-Emergent Adverse Reactions in Controlled Studies</caption> <col align="left" valign="bottom" width="33%"/> <col align="center" valign="top" width="13%"/> <col align="center" valign="top" width="13%"/> <col align="center" valign="top" width="13%"/> <col align="center" valign="top" width="13%"/> <col align="center" valign="top" width="15%"/> <thead> <tr> <th> </th> <th>Placebo</th> <th>KAPIDEX 30 mg</th> <th>KAPIDEX 60 mg</th> <th>KAPIDEX Total</th> <th>Lansoprazole 30 mg</th> </tr> <tr> <th>Adverse Reaction</th> <th>(N=896) %</th> <th>(N=455) %</th> <th>(N=2218) %</th> <th>(N=2621) %</th> <th>(N=1363) %</th> </tr> </thead> <tbody> <tr> <td>Diarrhea</td> <td>2.9</td> <td>5.1</td> <td>4.7</td> <td>4.8</td> <td>3.2</td> </tr> <tr> <td>Abdominal Pain</td> <td>3.5</td> <td>3.5</td> <td>4.0</td> <td>4.0</td> <td>2.6</td> </tr> <tr> <td>Nausea</td> <td>2.6</td> <td>3.3</td> <td>2.8</td> <td>2.9</td> <td>1.8</td> </tr> <tr> <td>Upper Respiratory Tract Infection</td> <td>0.8</td> <td>2.9</td> <td>1.7</td> <td>1.9</td> <td>0.8</td> </tr> <tr> <td>Vomiting</td> <td>0.8</td> <td>2.2</td> <td>1.4</td> <td>1.6</td> <td>1.1</td> </tr> <tr> <td>Flatulence</td> <td>0.6</td> <td>2.6</td> <td>1.4</td> <td>1.6</td> <td>1.2</td> </tr> </tbody> </table>