NEWS FROM USA
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
28 Sep 2018 |
Amikacin inhalation liposomal suspension |
Insmed |
Arikayce |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
27 Sep 2018 |
Ajanta Pharma |
N/A |
Three |
|
|
28 Sep 2018 |
Aurobindo pharma |
Solodyn (Medicis) |
Six |
|
|
1 Oct. 2018 |
Desoximetasone Cream |
Zydus |
Topicort 0.25% (Taro) |
Six |
*For more details on ANDA approvals click on the Drug Product Name
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Imatinib tablets |
Dr. Reddy’s |
Gleevec (Novartis) |
$ 868 Mn |
OTHER NEWS FROM US
Kyprolis (Carfilzomib): Approval of Once weekly dosing option in combination with dexamethasone for Relapsed or Refractory Multiple Myeloma
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