When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.
For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.
A Republican congressman from Alabama has proposed a stopgap bill that would fund the Food and Drug Administration through the middle of December or until the government shutdown ends, though it is unlikely to pass in the Senate.
Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.
Next year, the share of brand-name drugs paid by Medicare Part D beneficiaries will drop to 47.5%. The share of generics will drop to 72%, according to a report published Monday in the Wall Street Journal.