Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
In the latest tack by a pharmaceutical maker to delay generic competition, Irish specialty drug maker Warner Chilcott PLC is trying something new: adding a line across the top of a tablet.
The line, or "score," doesn't affect the chemical composition of Warner Chilcott's Doryx medicine for severe acne. Rather, it makes it easier for patients to divide and take the tablets in thirds, according to the company's filing with the U.S. Food and Drug Administration.
If U.S. regulators accept Warner Chilcott's argument, generic drug makers seeking to copy Doryx will have to give their proposed generic versions a makeover to match the double lines. That could delay the approval of low-priced generic alternatives.
http://online.wsj.com/article/SB10001424052970204294504576615273524482778.html
The line, or "score," doesn't affect the chemical composition of Warner Chilcott's Doryx medicine for severe acne. Rather, it makes it easier for patients to divide and take the tablets in thirds, according to the company's filing with the U.S. Food and Drug Administration.
If U.S. regulators accept Warner Chilcott's argument, generic drug makers seeking to copy Doryx will have to give their proposed generic versions a makeover to match the double lines. That could delay the approval of low-priced generic alternatives.
http://online.wsj.com/article/SB10001424052970204294504576615273524482778.html