NEWS FROM USA
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
24 Sep 2018 |
Duvelisib Capsule |
Verastem |
Copiktratm |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
21 Sep 2018 |
Aurobindo |
Sustiva (BMS) |
Five |
|
|
21 Sep 2018 |
Cipla |
Albenza (Impax Labs) |
None |
|
|
24 Sep 2018 |
Mylan |
Reyataz (BMS) |
Three |
|
|
24 Sep 2018 |
Yichang Humanwell |
Glucophage XR (BMS) |
Nineteen |
*For more details on ANDA approvals click on the Drug Product Name
Highlighted product indicates first US generic for respective RLD.
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
24 Sep 1018 |
Topiramate extended release capsules (Corresponding RLD: Trokendi XR) |
Par Pharm |
Other News from US
FDA publishes Final Guidance on ANDA submissions – content and format
Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C (Combined quarterly sales of these products: 831 Mn $)
NEWS FROM EUROPE
Positive CHMP opinions (EMA)
|
Drug |
Sponsor |
Indication |
|
Lilly |
Prophylaxis of Migraine |
|
|
Astellas |
non-metastatic castration-resistant prostate cancer (nmCRPC) |
|
|
in combination with Rituximab |
Abbvie |
Chronic Lymphocytic Leukemia |
|
Theravance |
moderate to severe chronic obstructive pulmonary disease (COPD) |
CHMP positive opinion is one of the final steps before a final decision on the regulatory update is granted by the European Commission.
New Authorizations
European Commission approves Imfinzi for locally-advanced, unresectable NSCLC
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