Zydus Lifesciences arm bags tentative approval from USFDA for Canagliflozin, Metformin Hydrochloride Tablets
The drug will be manufactured at the group's formulation manufacturing facility at Moraiya.;
Ahmedabad: Zydus Lifesciences Limited’s (including its subsidiaries/affiliates hereafter referred to as “Zydus”) subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) for Canagliflozin and Metformin Hydrochloride Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg (USRLD: Invokamet Tablets).
Canagliflozin and metformin combination product is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing metformin or canagliflozin or in patients already being treated with both canagliflozin and metformin.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya.
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of USD 49.4 mn in the United States (IQVIA MAT Dec. 2022). The group now has 344 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04, the company said.
Medical Dialogues team had earlier reported that Zydus Lifesciences Limited had received tentative approval from the United States Food and Drug Administration (USFDA) to market Canagliflozin Tablets, 100 mg and 300 mg (USRLD: Invokana Tablets).
Read also: Zydus Lifesciences bags tentative USFDA nod for Canagliflozin Tablets
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.
Read also: Zydus Lifesciences arm gets USFDA nod for Postherpetic Neuralgia drug Gabapentin
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.