NEWS FROM USA
New Paragraph IV filing
|
DRUG |
Dosage form |
Corresponding RLD |
Date of Submission |
Type of Submission (Based on Date) |
|
Bosentan |
Tablet for Oral Suspension |
Tracleer |
08 Feb 2019 |
Open First to File# |
|
Lenvatinib |
Capsules |
Lenvima |
13 Feb 2019 |
NCE-1 |
|
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid |
Oral solution |
Clenpiq |
11 Feb 2019 |
Open First to File* |
#NDA for Bosentan dispersible tablets were approved on 5 Sep. 2017. First PIV filing was done after 17 months of NDA approval.
*Clenpiq is solution version of prepopik powder. NDA for Clenpiq was approved on 28 Nov. 2017. First PIV filing was done within15 months of NDA approval.
Source: fda.gov
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Testosterone Gel |
Lupin |
AndroGel |
$893 Million |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
09 Apr 2019 |
Umedica |
Crestor (IPR) |
More Than 20 |
|
|
09 Apr 2019 |
Hydroxyprogesterone Caproate Solution (1250 mg/5 ml) |
Sun Pharm |
Makena (Amag Pharma) |
One (Slayback) |
|
11 Apr 2019 |
Lupin |
Androgel (Abbvie) |
Four |
NEWS FROM INDIA
Beclomethasone-Formoterol inhaler (Cipla): Cipla launches Niveoli India’s first extrafine ICS-LABA combination HFA inhaler
If you have any query/suggestion then please write us at pharmacaption@gmail.com
No comments:
Post a Comment