Pharma Industrial India Magazine - May-June 2024

Alembic Pharma Secures USFDA Tentative Approval for Bosutinib Tablets Cipla and Takeda to Commercialize Vonoprazan in India Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Ab- breviated New Drug Application (ANDA) for Bosutinib Tablets, 100 mg and 500 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism C.V. (PF Prism). Bosutinib tablets are indicated for the treatment of a certain type of leukemia called Philadelphia chromosome-posi- tive chronic myelogenous leukemia. Re- fer label for a detailed indication. Bosutinib Tablets, 100 mg and 500 mg have an estimated market size of USD 275 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 206 ANDA approvals (179 final approvals and 27 tentative approvals) from USF- DA. Cipla has signed a non-exclusive Pat- ent License agreement with Takeda Pharmaceutical company Ltd. for ‘Vo- noprazan’ for India Market for treating acid-related illnesses among patients. This deal is meant to commercialise the drug in India under Cipla’s own trade- mark brands. Vonoprozan (oral tablets) is a novel potassium-competitive acid blocker (P-CAB), used for the treatment of relat- ed disorders - Gastroesophageal Reflux Disease (GERD). Vonoprozan will help in treating dis- orders such as erosive oesophagitis, gastric ulcer, duodenal ulcer, peptic ul- cer, gastro- oesophageal reflux, reflux oesophagitis and Helicobacter pylori eradication. Achin Gupta, CEO – One India Busi- ness, Cipla Ltd., said, “Bringing new and advanced therapies to the Indian market has always been a key area of focus for us. We believe this partnership will not only address a significant med - ical need, but also strive to provide a better quality of life for patients.” In November 2023, Vonoprazan was ap- proved by the US FDA for healing and maintenance of healing of all grades of Erosive esophagitis and relief of heart- burn associated with Erosive esophagi- tis and in combination with amoxicillin and clarithromycin or amoxicillin alone for the treatment of Helicobacter pylori (H. pylori) infection in adults. NEWS PHARMA INDUSTRIALINDIA · MAY-JUN 24 10