Ibuprofen and famotidine

FDA Drug Profile — Ibuprofen and famotidine, IBUPROFEN AND FAMOTIDINE

Drug Details

Generic Name
Ibuprofen and famotidine
Brand Names
Ibuprofen and famotidine, IBUPROFEN AND FAMOTIDINE
Application Number
ANDA203658
Sponsor
ENDO USA, Inc.
NDC Codes
15
Dosage Forms
TABLET, TABLET, FILM COATED
Routes
ORAL
Active Ingredients
FAMOTIDINE, IBUPROFEN

Indications and Usage

1 INDICATIONS AND USAGE Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies ( 14 ), Use in Specific Populations ( 8.5 )] . Ibuprofen and famotidine tablet, a combination of a nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months. ( 1 )