FDA tentatively approves generic Crestor
MUMBAI, India The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Sun Pharmaceutical Industries.
Sun announced Wednesday the tentative approval of rosuvastatin calcium tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths.
The drug is a generic version of AstraZeneca’s Crestor, which had annual sales of around $3.4 billion in the United States, according to Sun. Sun did not disclose when it would begin marketing its version of the drug, though Crestor will lose patent protection for use in adults in December 2021, according to FDA data.