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In a major development, Aurobindo Pharma announced on Wednesday that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market cholesterol lowering Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base).
The approved product has an estimated market size of $6.7 billion for the twelve months ending May 2016, the company said citing IMS Health data.
Aurobindo was one of the first Abbreviated New Drug Application (ANDA) applicants to submit a substantially complete ANDA with a paragraph IV certification, therefore, it was eligible for 180 days of generic drug shared exclusivity, the company claimed. The product is launched in the US market.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) CRESTOR (rosuvastatin calcium) Tablets 5 mg, 10 mg, 20 mg and 40 mg of IPR Pharmaceuticals.
Rosuvastatin Calcium Tablets is an antihyperlipidemic to prevent cardiovascular disease. It is used to reduce elevated total-C, LDL-C, ApoB, non HDL-C, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia, according to a company statement.
