Dapagliflozin Tablets
Form: Tablets
Strength: 5 mg and 10 mg
Reference Brands: Forxiga(US & EU)
Category: Diabetes
Dapagliflozin, an SGLT2 inhibitor, is approved in both the USA and EU for treating type 2 diabetes, heart failure, and chronic kidney disease. In the USA, it is marketed as Farxiga®, approved via an NDA under 21 CFR, requiring robust safety labeling for risks like ketoacidosis and UTIs. In the EU, it is approved as Forxiga® through the centralized procedure by the EMA, with CTD-format submission, RMP, PSURs, and strict pharmacovigilance. Manufacturers must comply with GMP and post-marketing obligations. For regulatory consulting, global B2B sourcing, or dossier support, visit PharmaTradz.com.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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