NEWS FROM USA
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
26 Nov 2018 |
Larotrectinib Capsules |
Loxo |
Vitrakvi |
|
|
26 Nov 2018 |
Larotrectinib Oral Solution |
Loxo |
Vitrakvi |
505(b)2 products in pipeline
Riluzole sublingual, oral disintegrating tablet (Biohaven): Biohaven Announces FDA Acceptance of 505(b)(2) NDA Filing for Riluzole for the Treatment of Amyotrophic Lateral Sclerosis
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
27 Nov 2018 |
Alembic |
Restoril (Specgx) |
Five |
|
|
26 Nov 2018 |
Alembic |
Xylocaine (Astrazeneca) |
Ten |
|
|
26 Nov 2018 |
Akorn |
VOLTAREN (NOVARTIS) |
Four |
|
|
23 Nov 2018 |
Celerity Pharms |
Integrilin (Schering) |
Seven |
|
|
23 Nov 2018 |
Lifepharma |
N/A |
Ten |
|
|
23 Nov 2018 |
Macleods |
Triamcinolone Acetonide (Mylan) |
Three |
|
|
23 Nov 2018 |
Potassium Chloride Oral Solution
|
Epic Pharma |
Potassium Chloride (Pharma Res) |
Two (Upsher, Novel) |
|
23 Nov 2018 |
Aptapharma |
Children's Motrin (J And J Consumer) |
Nine |
|
|
23 Nov 2018 |
Novitium |
N/A |
N/A |
|
|
23 Nov 2018 |
Ingenus |
N/A |
Two (Fresenius, West Ward) |
|
|
23 Nov 2018 |
Aleor |
N/A |
Ten |
|
|
23 Nov 2018 |
Zydus |
N/A |
Eleven |
USFDA inspections
Lupin's Tarapur facility receives EIR from US FDA
NEWS FROM EUROPE
Final approval from (EMA)
|
Drug |
Sponsor |
Indication |
|
Sandoz |
Neutropenia and febrile neutropenia in adult cancer patients treated with chemotherapy |
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