USFDA has published the list of new molecular entities (NMEs) approved by FDA's Center for Drug Evaluation and Research (CDER) during calendar year 2010.
The list includes total 21 molecules out of which 15 are NDA approvals and rest 6 are new BLA (Biologic licence approval)
List is available here
FDA has also updated Paragraph IV certification list as of 7 February 2011. Table shows the newly added molecule.
The list includes total 21 molecules out of which 15 are NDA approvals and rest 6 are new BLA (Biologic licence approval)
List is available here
FDA has also updated Paragraph IV certification list as of 7 February 2011. Table shows the newly added molecule.
| DRUG NAME | DOSAGE FORM | STRENGTH | RLD | DATE OF SUBMISSION |
| Oseltamivir Phosphate | Capsule | 75 mg | Tamiflu | 11/15/2010 |
| Tacrolimus | Ointment | 0.03% | Protopic | 11/22/2010 |
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