NEWS FROM THE USA
505 (b) 2s in pipeline
Naloxone Pre-Filled Single Dose Syringe (Adamis Pharma): Adamis Pharma announced the submission of a NDA to USFDA for naloxone pre-filled single dose syringe (PFS) for the treatment of an opioid overdose.
Monomethyl Fumarate Prodrug (Banner Pharma): Banner pharma Banner Receives FDA Tentative Approval for BAFIERTAM for the Treatment of Relapsing Forms of Multiple Sclerosis.
NEW GENERICS LAUNCHES IN THE US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Epinephrine Inhalation Aerosol Bronchodilator Suspension |
Amphastar Pharmaceutical |
Primatene (Mist) |
$ 0.7 Billion |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
03 Jan 2019 |
Alembic |
Mirapex Er (Boehringer) |
Six |
|
|
02 Jan 2019 |
Teligent Pharma |
N/A |
Four Plan To Launch In February Of 2019 |
|
|
03 Jan 2019 |
Amneal |
Latuda (Sunovion) |
Four |
|
|
03 Jan 2019 |
Invagen |
Latuda (Sunovion) |
Four |
|
|
03 Jan 2019 |
Lupin |
Latuda (Sunovion) |
Four |
|
|
03 Jan 2019 |
Accord |
Latuda (Sunovion) |
Four |
|
|
03 Jan 2019 |
Torrent |
Latuda (Sunovion) |
Four |
Teva and Amgen Resolve Ongoing Dispute Over Teva’s Generic Cinacalet HCl Product
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
02 Jan 2019 |
Micro Labs |
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