Ash Stevens has submitted a number of New Chemical Entities – some approved in near-record time. With proactive attention to Food and Drug Administration (FDA) and global requirements, we understand regulations and requirements, and minimize review time so you can reach the market quickly. Our team of scientists has a solid foundation in chemical synthesis. To gain approvals quickly, we understand the regulatory and FDA approval process including documentation requirements, quality systems, process development, analytical support and validation.
Currently, we have 11 approvals – four were approved in less than two years. Some of our Active Pharmaceutical Ingredients for approved drug product include:
Fludarabine Phosphate for Fludara® |
NAME |
STRUCTURE |
INDICATION |
NDA NUMBER |
YEAR APPROVED |
Fludarabine phosphate |
 |
Adult leukemia |
20-038
major manufacturing supplement |
1991, 2002 |
TOP
Brimonidine Tartrate for Alphagan® |
NAME |
STRUCTURE |
INDICATION |
NDA NUMBER |
YEAR APPROVED |
Brimonidine tartrate |
 |
Glaucoma |
20-613
21-262 |
1996, 2001 |
TOP
4-Methylpyrazole for Antizol® |
NAME |
STRUCTURE |
INDICATION |
NDA NUMBER |
YEAR APPROVED |
4-Methyl-
pyrazole |
 |
Ethylene glycol or methanol poisoning |
20-696 |
1997 |
TOP
Busulfan for Busulfex® |
NAME |
STRUCTURE |
INDICATION |
NDA NUMBER |
YEAR APPROVED |
Busulfan |
 |
Pre-treatment regimen for bone marrow transplant |
20-954 |
1999 |
TOP
Floxuridine, USP |
NAME |
STRUCTURE |
INDICATION |
NDA NUMBER |
YEAR APPROVED |
Floxuridine, USP |
 |
Antimetabolite for treatment of some cancers |
ANDA 075387 |
2000 |
TOP
Bortezomib for Velcade® |
NAME |
STRUCTURE |
INDICATION |
NDA NUMBER |
YEAR APPROVED |
Bortezomib |
 |
Multiple myeloma |
21-602 |
2003 |
TOP
Azacitidine for Vidaza® |
NAME |
STRUCTURE |
INDICATION |
NDA NUMBER |
YEAR APPROVED |
Azacitidine |
 |
All myelodysplastic syndromes (MDS) |
50-794 |
2004 |
TOP
Clofarabine for Clolar® |
NAME |
STRUCTURE |
INDICATION |
NDA NUMBER |
YEAR APPROVED |
Clofarabine |
 |
Acute pediatric lymphoblastic leukemia |
21-673 |
2004 |
TOP
Anagrelide HCl monohydrate |
NAME |
STRUCTURE |
INDICATION |
NDA NUMBER |
YEAR APPROVED |
Anagrelide hydrochloride monohydrate |
 |
Thrombocytosis |
ANDA 076417 |
2005 |
TOP