PREVACID® I.V. (LANSOPRAZOLE) APPROVED BY THE FDA FOR THE TREATMENT OF ACID REFLUX DISEASE IN HOSPITALIZED PATIENTS

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FDA Approves Prevacid

PREVACID® I.V. (LANSOPRAZOLE) APPROVED BY THE FDA FOR THE TREATMENT OF ACID

REFLUX DISEASE IN HOSPITALIZED PATIENTS

-New Administration Option for Leading Proton Pump Inhibitor-

LAKE FOREST, Ill., [May 2004] ­ TAP Pharmaceutical Products Inc. announced

today it has received U.S. Food and Drug Administration (FDA) approval to

market an intravenous (I.V.) formulation of PREVACID® (lansoprazole) as an

alternative for short-term (up to seven days) treatment of all grades of

erosive esophagitis when patients are unable to take solid oral formulations

of PREVACID. Erosive esophagitis is a condition in which the lining of the

esophagus has been damaged.

" I.V. treatment can provide an important treatment bridge for managing

severe to mild erosive esophagitis in patients who are unable to take

medication by mouth, " said Xavier Frapaise, M.D., vice president of research

and development at TAP. " Once the patient is able to take medication by

mouth, therapy can be switched to an oral formulation of PREVACID to help

them continue to manage their symptoms for a total of six to eight weeks. "

The safety and efficacy of PREVACID I.V. for Injection as an initial

treatment of erosive esophagitis have not been demonstrated. Treatment with

PREVACID I.V. for Injection should be discontinued as soon as the patient is

able to resume treatment with oral formulations...

In four U.S. trials involving 161 patients, the following treatment-related

adverse events were reported in 1% or more of patients treated with PREVACID

I.V.: headache (1.0%), injection site pain (1.0%), injection site reaction

(1.0%) and nausea (1.3%). PREVACID I.V. is contraindicated in patients with

known hypersensitivity to any component of the formulation. Please see

complete prescribing information and visit www.prevacid.com.

About Oral PREVACID® (lansoprazole)

PREVACID is the only PPI indicated for the healing and risk reduction of the

recurrence of gastric (stomach) ulcers associated with NSAIDs (non-steroidal

anti-inflammatory drugs) in chronic NSAID users. Controlled studies for

healing did not extend beyond eight weeks. Controlled studies for risk

reduction of recurrence and maintenance did not extend beyond twelve weeks.

PREVACID is also the only PPI indicated for maintenance treatment of healed

duodenal ulcer, and the only PPI approved for use in the short-term

treatment of symptomatic GERD and erosive esophagitis in children ages 1 to

11 years. Safety and effectiveness in children younger than one and aged 12

to 17 have not been established.

PREVACID also is indicated for the short-term treatment of heartburn and

other symptoms of gastroesophageal reflux disease (GERD); the short-term (up

to eight weeks) healing, symptom relief and maintenance of healed erosive

esophagitis, a condition in which the lining of the esophagus has been

damaged; the short-term treatment of active benign gastric (stomach) ulcers;

the short-term (up to four weeks) treatment of duodenal ulcer (ulcers found

on the first part of the small intestine); the long-term treatment of

pathological hypersecretory conditions (which involve the overproduction of

stomach acid), including Zollinger-Ellison Syndrome. Controlled studies for

maintenance indications did not extend beyond 12 months.

Symptomatic response to therapy does not preclude the presence of serious

stomach problems. PREVACID is contraindicated in patients with known

hypersensitivity to any component of the formulation. The most frequently

reported adverse events in adults include diarrhea (3.8%), abdominal pain

(2.1%), and nausea (1.3%). In pediatric GERD patients between the ages of 1

to 11 the most frequently reported adverse events were constipation (5%) and

headache (3%). For further information about PREVACID, please see the

complete prescribing information and visit www.prevacid.com. ...

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