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Endo International plc announced that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the first generic version of Allergan's Pylera (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) 140 mg, 125 mg and 125 mg capsules in the US, following final approval from the US Food and Drug Administration of its Abbreviated New Drug Application.
"We're proud to be a reliable, quality supplier providing choices to healthcare professionals and their appropriate patients," said Scott Sims, senior vice president and general manager, injectable solutions & generics at Endo. "This first-to-market generic product strengthens our portfolio and is a lower-cost option for people who need the medication."
Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules, in combination with omeprazole, are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past five years) to eradicate H. pylori.
According to IQVIA, Pylera sales were approximately $30 million for the 12 months ended December 31, 2022.
Pylera is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate.
Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies.
Par Pharmaceutical develops, manufactures and markets innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patients' lives.
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