NEWS FROM USA
ANDA Approvals
|
DRUG |
COMPANY |
Corresponding RLD |
Press release if available |
|
Fenofibrate Tablets |
Prinston |
Tricor (Abbvie) |
|
|
Lamivudine; Zidovudine Tablets |
Macleods |
Combivir (Viiv Healthcare) |
|
|
Potassium Chloride Solution |
Novel lab |
Potassium Chloride (Genus) |
|
|
Isosorbide Mononitrate ER Tablets |
Dexcel |
N/A |
|
|
Efavirenz Tablets |
Aurobindo |
Sustiva (BMS) |
|
|
Potassium Chloride Solution |
Lupin |
Potassium Chloride (Genus) |
NEW GENERICS LAUNCHES IN THE US
|
DRUG |
COMPANY |
Corresponding RLD |
Press Release |
|
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets |
Upsher smith lab |
Lomotil (Pfizer) |
NEW PARA IV ANDA FILINGS
|
DRUG |
Strength |
Corresponding RLD |
Filing date |
|
Abiraterone Acetate Tablets |
125 Mg |
Yonsa |
23 July 2018 |
|
Belinostat Injection |
500 Mg/Vial |
Beleodaq |
03 July 2018 |
|
Budesonide And Formoterol Fumarate Dihydrate Metered Inhalation |
80 Mcg/4.5 Mcg Per Inhalation And |
Symbicort |
26 June 2018 |
|
Esomeprazole Magnesium DR For Oral Suspension |
10 Mg |
Nexium |
06 July 2018 |
|
Vasopressin Injection |
20 Units/Ml, 10 Ml |
Vasostrict |
29 June 2018 |
NEWS FROM EUROPE
Alnylam Receives Approval of ONPATTRO (patisiran) in Europe
European Commission approves Nucala (mepolizumab) for the treatment of children with severe asthma
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