Lupin Gains U.S. FDA Approval for Dapagliflozin and Metformin Tablets
Filing Summary
Lupin Limited has received approval from the U.S. FDA for its Abbreviated New Drug Application for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. The approved dosages include 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg. Additionally, Lupin received tentative approval for the 2.5 mg/1,000 mg dosage. These tablets are bioequivalent to Xigduo® XR. Lupin is a global pharmaceutical company with a strong presence in the U.S. and India, focusing on various therapy areas including anti-diabetic products.
Lupin Limited announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. The approved dosages are 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg. The company also received tentative approval for the 2.5 mg/1,000 mg dosage.
The U.S. FDA has confirmed that Lupin’s tablets are bioequivalent to Xigduo® XR, which is used for the indications specified in the approved labeling. This approval allows Lupin to market these formulations in the United States, expanding its portfolio of anti-diabetic medications.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India. The company distributes its products in over 100 markets worldwide. Lupin specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a significant presence in the U.S. and India, focusing on therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
Lupin operates 15 manufacturing sites and 7 research centers globally, employing over 24,000 professionals. The company is committed to improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.