Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base).
This product is the generic version of Abbott Laboratories’ Teveten(Z) Tablets, which are used to treat hypertension.
Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification to the FDA for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base), and was awarded 180 days of marketing exclusivity. Mylan is shipping this product immediately.
Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base), had U.S. sales of approximately $ 4.9 million for the 12 months ending Sept. 30, 2011, according to IMS Health.
Currently, Mylan has 170 ANDAs pending FDA approval representing $ 98.4 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $ 26.8 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.
Mylan distributes generic and specialty pharmaceutical companies all over the world and provides products to customers in more than 150 countries and territories.
The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.
For more information about generic drugs, please visit www.ChoosingGenerics.com.