NEWS FROM USA
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Testosterone Gel |
Dr Reddys |
AndroGel |
$815.6 Million |
505(B)2 IN PIPELINE:
Amoxicillin/Rifabutin/Omeprazole combination (Redhill Biopharma): RedHill Biopharma Submits New Drug Application for Talicia (Amoxicillin/Rifabutin/Omeprazole) for H. pylori Infection.
- Talicia was granted Qualified Infectious Disease Product (QIDP) designation by the FDA.
- If approved, Talicia will receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of eight years of market exclusivity.
- Base on company’s press release, Talicia is also covered by U.S. patents which extend patent protection until at least 2034, with additional patents and applications pending in various territories worldwide.
- Full Press release: Link
NDA APPROVALS
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Prescribing information |
|
03 May 2019 |
Tafamidis Meglumine Capsules |
Foldrx Pharmaceuticals |
Vyndaquel |
|
|
03 May 2019 |
Tafamidis |
Foldrx Pharmaceuticals |
Vyndamax |
ANDA APPROVALS
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
01 May 2019 |
Macleods |
Epivir (Viiv Healthcare) |
More than 10 |
|
|
01 May 2019 |
DR Reddys |
Cubicin (Cubist Pharma) |
Five |
|
|
01 May 2019 |
Sun Pharma |
Depo-Provera (Pharmacia And Upjohn) |
Six |
|
|
01 May 2019 |
Medefil Inc |
Calcium Chloride 10% In Plastic Container (Hospira) |
Two (Intl Medication, Luitpold) |
|
|
02 May 2019 |
Invatech Pharma |
Blocadren (Merck) |
One (Mylan) |
|
|
02 May 2019 |
Accord |
Plan B One-Step (Fdn Consumer) |
More than 10 |
|
|
03 May 2019 |
US Worldmeds |
Alkeran (Apotex) |
Seven |
|
|
03 May 2019 |
Aurobindo |
Lasix (Sanofi) |
Seven |
TENTATIVE ANDA APPROVALS
|
Approval Date |
Drug |
Company |
|
07 May 2019 |
Lupin |
USFDA INSPECTIONS:
Strides (Puducherry facility): USFDA classifies Strides Puducherry facility as Official Action Initiated (OAI).
- USFDA classified the Puducherry facility as Official Action Initiated (OAI) based on the inspection conducted from 28th January - 5th February 2019.
- Puducherry has 10 ANDAs where the Company expects delays until the facility is reclassified.
- Full Press release: Link
Alembic JV (Formulation facility-Karkhadi): Aleor Dermaceuticals Ltd., Received Establishment Inspection Report (EIR) For Its Formulation Facility At Karkhadi.
- USFDA had carried out inspection in this facility between 4 February 2019 to 8 February 2019.
- Aleor Dermaceuticals Ltd. (Aleor) is a 60:40 Joint Venture between Alembic Pharmaceuticals Ltd and Orbicular Pharmaceutical Technologies Pvt. Ltd.
- Full Press Release: Link
NEWS FROM EUROPE
Fresenius kabi launches Adalimumab biosimilar in Germany
- Full Press release: Link
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