NEWS FROM USA
505 (b) 2s in pipeline
Tadalafil Sublingual Tablets (Adamis Pharma): Adamis pharama submits NDA application to the USFDA for its fast dissolving sublingual tadalafil tablets for the treatment of erectile dysfunction.
Dexmedetomidine Sublingual film (Bioxcel Therapetics): The U.S. FDA has granted Fast Track Designation for its investigational drug BXCL501 in the treatment of acute agitation
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Pimecrolimus cream 1% |
Teva Pharma |
Elidel |
218.4 Mn USD |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
26 Dec 2018 |
Sandoz |
Gris-Peg (Valeant) |
Two (Mountain, Sigmapharm) |
|
|
26 Dec 2018 |
Bionpharma |
Zithromax (Pfizer) |
Eight |
|
|
26 Dec 2018 |
Amneal Pharms |
N/A |
Ten |
|
|
27 Dec 2018 |
Watson Labs |
Sensipar (Amgen) |
Seven |
|
|
27 Dec 2018 |
Usv North |
Sandostatin (Novartis) |
Six |
|
|
27 Dec 2018 |
Actavis |
Elidel (Valeant) |
None |
|
|
27 Dec 2018 |
Qingdao Baheal |
Fortamet (Andrx Labs) |
Four |
|
|
27 Dec 2018 |
Hospira |
Clolar (Genzyme) |
Seven |
|
|
29 Dec 2018 |
Zydus |
Duac (Stiefel) |
Three |
Highlighted product indicates first generic approval for the corresponding RLD.
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
26 Dec 2018 |
Dr Reddys |
|
|
26 Dec 2018 |
Pharmtak |
|
|
26 Dec 2018 |
Pharmtak |
|
|
27 Dec 2018 |
Aurobindo |
|
|
27 Dec 2018 |
Cadila |
NEWS RELATED TO GENERIC PATENT LITIGATION
Methylphenidate XR-ODT (Cotempla XR-ODT): Neos Therapeutics Announces Settlement with Teva on Cotempla XR-ODT Patent Litigation
If you have any query/suggestion then please write us at pharmacaption@gmail.com
No comments:
Post a Comment