News from USA
|
DRUG |
COMPANY |
NEWS |
|
Deferasirox Tablet |
Zydus |
Zydus receives tentative approval from the USFDA for Deferasirox Tablets for Oral Suspension |
|
Incobotulinumtoxin A |
Merz |
FDA APPROVES INCOBOTULINUMTOXINA FOR ADULT PATIENTS WITH SIALORRHEA |
Other ANDA Approvals
|
DRUG |
COMPANY |
Corresponding RLD |
|
Levonorgestrel |
Haupt Pharma |
Plan B One-Step (Fdn Consumer) |
|
Budesonide |
Actavis |
Uceris (Valeant Pharms Intl) |
|
Olanzapine |
HEC |
Zyprexa Zydis (Lilly) |
|
Haloperidol Decanoate |
Somerset therapeutics |
Haldol (Janssen Pharms) |
|
Temozolomide |
Apotex |
Temodar (Merck Sharp Dohme) |
|
Phenylephrine Hydrochloride |
Amneal |
Vazculep (Avadel) |
Tentative Approvals
|
DRUG |
COMPANY |
Corresponding RLD |
|
Tadalafil |
Watson |
Cialis (Lilly) |
New Paragraph IV filing
|
DRUG |
Dosage form |
Corresponding RLD |
Date of Submission |
|
Tiotropium Bromide |
Inhalation Powder Capsules |
Spiriva |
11 May 2018 |
NEWS FORM UK
|
DRUG |
COMPANY |
NEWS |
|
Pyridoxine/doxylamine (Diclectin) |
ALLIANCE PHARMA |
MHRA approves UK marketing authorisation application for Diclectin
|
|
Lenalidomide (Revlimid) |
Celgene |
Celgene (CELG) Settles Litigation with Accord Healthcare Relating to Patents for REVLIMID Permitted launch of accord beginning on 18 Jan. 2022 in the UK |
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