Mylan Launches Orapred Generic; Lupin Launches Authorized Generic of Celebrex

In recent generic drug developments, Mylan Inc. has launched a generic version or Orapred and Lupin Ltd. has launched an authorized generic version of Celebrex.

Mylan Dec. 11 announced that it has launched the first generic version of Shionogi’s Orapred ODT (prednisolone sodium phosphate) 10 mg, 15 mg and 30 mg orally disintegrating tablets.

The company said it received final approval from the Food and Drug Administration for this product and was awarded 180 days of generic drug marketing exclusivity. Under the Hatch-Waxman Act, the first company to file an abbreviated new drug application (ANDA) with a paragraph IV certification ...