Alembic Pharma Gets USFDA Nod for Heart Failure Treatment Tablets

Alembic Pharmaceuticals received final approval from the United States Food and Drug Administration (USFDA) on Thursday, May 30 for its Abbreviated New Drug Application (ANDA) for Sacubitril and Valsartan tablets of 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.

Key Takeaways from Alembic Pharma:

• Alembic Pharmaceuticals received final approval from the USFDA for its ANDA for Sacubitril and Valsartan.
• Sacubitril and Valsartan are used to reduce heart failure in adults with chronic heart failure.
• The tablets are useful in treating symptomatic heart failure in one year and older children.

Both these tablets, Sacubitril and Valsartan are used to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure. The tablets are useful in treating symptomatic heart failure in children aged one year and older.

The approved drug is therapeutically equivalent to the Reference Listed Drug (RLD) product, Entresto tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, of Novartis Pharmaceuticals Corporation (Novartis).

About Alembic Pharmaceuticals Limited:

Alembic Pharmaceuticals Limited was established in 1907 with its headquarters in India. It is a vertically integrated research and development pharmaceutical company at the forefront of healthcare. Alembic manufactures and markets generic pharmaceutical products all over the world. Regulatory authorities of many developed countries including the USFDA approve its research and manufacturing facilities. The company is one of the leaders in branded generics in India. Doctors and patients recognise Alembic's brands as it is marketed through a team of over 5000. 

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