NEWS FROM USA
NDA Approvals
|
DRUG |
COMPANY |
Comment |
|
Glycopyrrolate
(0.2mg/ml)
Approval Date: 11 July 2018 |
Exela Pharma |
|
|
Tecovirimat
(200 Mg, Oral Capsule)
Approval Date: 13 July 2018 |
Siga Technologies |
ANDA Approvals
|
DRUG |
COMPANY |
Corresponding RLD |
|
Dalfampridine |
Accord Healthcare |
Ampyra (Acorda) |
|
Dihydroergotamine Mesylate |
Sagent Pharms |
D.H.E. 45 (Valeant) |
|
Guaifenesin |
Amneal Pharms |
Mucinex (Reckitt Benckiser) |
Tentative ANDA Approvals
|
DRUG |
COMPANY |
Corresponding RLD |
|
Cabazitaxel |
Apotex |
Jevtana (Sanofi ) |
|
Mesalamine |
Teva |
N/A |
Other News from US
Suboxone from DR Reddy:
Indivior
is granted preliminary injunction on generic buprenorphine and naloxone
sublingual film
NEWS FROM EU
New dosage form authorization
|
DRUG/ DOSAGE FORM |
COMPANY |
Comment |
|
Dasatinib powder for oral suspension
Approval date: 09 July 2018 |
Bayer |
Previously approved dosage form: Tablets
Source: EMA |
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