FDA Wins Court Battle and Approves 8 Crestor ANDAs

The FDA approved eight ANDAs for AstraZeneca’s blockbuster cholesterol drug Crestor after a federal judge denied the company’s bid to stave off the approvals.

A company spokeswoman confirmed that U.S. District Court Judge Randolph Moss rejected a temporary order the company requested in its suit against the FDA over generic labeling for the drug, a decision that paved the way for the generic approvals.

The FDA already had granted tentative approval to all of the ANDAs, which came from Sun Pharmaceuticals, Aurobindo Pharma, Mylan, Teva Pharmaceuticals, Apotex, Par Pharmaceutical, Glenmark Pharmaceuticals and Sandoz.