|
Approved Active Moieties for which FDA has Issued a
Written
Request for Pediatric Studies under Section 3 of the
Best
Pharmaceuticals for Children Act
Note: This list identifies approved active moieties that no longer have patent protection or marketing exclusivity and
for which
FDA has issued a Written Request for pediatric studies in
accordance with Section 3 of the Best Pharmaceuticals for Children Act. This
page lists only innovators or reference listed holders to which FDA
has issued a Written Request.
For a complete list of all approved application holders, please see the Orange
Book (http://www.fda.gov/cder/ob/default.htm).
Total Approved Active Moieties with No Marketing Protection
for which FDA has Issued a Written Request = 9
|
Active Moiety |
Sponsor |
|
Azithromycin * |
Pfizer |
| Baclofen |
Medtronic/Watson |
| Dactinomycin |
Merck |
| Lithium |
Roxane/GSK/Solvay |
| Lorazepam |
Baxter/Roxane/Biovail |
| Meropemem |
AstraZeneca |
| Rifampin |
Aventis |
| Sodium
Nitroprusside |
Abbott |
| Vincristine |
Eli Lilly |
* Active moiety granted second Written Request.
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Date created: October 31, 2003; Updated: September 30, 2004 |
