The Food and Drug Administration (FDA) has approved Endo’s Abbreviated New Drug Application (ANDA) for the first generic version of Pylera® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) capsules.
Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride capsules are indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori (H. pylori) infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
Each capsule contains 140mg of bismuth subcitrate potassium, 125mg of metronidazole, a nitroimidazole antimicrobial, and 125mg of tetracycline hydrochloride, a tetracycline class antimicrobial. The product is supplied as a 10 day therapy pack containing 10 blister cards, with each card containing 12 capsules for a total of 120 capsules.
Par Pharmaceuticals announced that shipping of the generic product has commenced.
- Endo launches first generic version of Pylera® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) capsules. News release. Endo International plc. Accessed March 10, 2023. https://www.prnewswire.com/news-releases/endo-launches-first-generic-version-of-pylera-bismuth-subcitrate-potassium-metronidazole-tetracycline-hydrochloride-capsules-301768573.html.
- Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride capsules. Package insert. Endo International plc; 2023. Accessed March 10, 2023. https://www.endodocuments.com/documents/Bismuth/Bismuth_PI.pdf.