NEWS FROM USA
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
27 Sep 2018 |
Dacomitinib Tablets |
Pfizer |
Vizimpro |
|
|
27 Sep 2018 |
Galcanezumab-Gnlm Injection |
Eli Lilly And Co |
Emgality |
New Strength Approval For Existing NDA
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Strength |
|
27 Sep 2018 |
Epinephrine |
Adamis Pharms |
Symjepi |
0.15 mg for paediatric use |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
26 Sep 2018 |
Aurolife Pharma |
N/A |
One (Mayne Pharma) |
|
|
26 Sep 2018 |
Guardian |
Children's Motrin (J And J Consumer Inc) |
Two (L Perrigo And Tris Pharma) |
|
|
26 Sep 2018 |
Abhai Llc |
N/A |
Seven |
|
|
26 Sep 2018 |
Amneal Pharms |
EVEKEO (Arbor) |
None |
*For more details on ANDA approvals click on the Drug Product Name
*Highlighted product has received Competitive Generic Therapy designation
Planned ANDA submission with granted Competitive Generic Therapy designation
|
Drug Product |
ANDA Sponsor |
Comment |
Source of Information / Link |
|
Minocycline Hydrochloride Microspheres 1 mg |
Profounda Inc. |
USFDA granted CGT designation for planned ANDA submission |
PR Newswire |
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
25 Sep 2018 |
Tofacitinib |
Prinston Pharma |
|
26 Sep 2018 |
Linagliptin; Metformin Hydrochloride |
Msn Labs Pvt |
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Tadalafil Tablets (Cialis) |
Teva (Will be lone generic player for first 180 days) |
Cialis (Lilly) |
$1.93 Billions |
New Paragraph IV filing
|
DRUG |
Dosage form |
Corresponding RLD |
Date of Submission |
Type of Submission (Based on Date) |
|
Empagliflozin |
Tablets |
Jardiance |
01 Aug 2018 |
NCE-1 |
|
Empagliflozin And Metformin Hydrochloride |
Tablets |
Synjardy |
01 Aug 2018 |
NCE-1 |
|
Empagliflozin And Metformin Hydrochloride |
Extended-Release Tablets |
Synjardy XR |
01 Aug 2018 |
NCE-1 |
|
Empagliflozin And Linagliptin |
Tablets |
Glyxambi |
01 Aug 2018 |
NCE-1 |
|
Deoxycholic Acid |
Injection |
Kybella |
13 July 2018 |
NCE-1 |
|
Morphine Sulphate And Naltrexone Hydrochloride (20 Mg/0.8 Mg) |
Extended-Release Capsules |
Embeda |
16 Aug 2018 |
Open filing |
|
Tavaborole |
Topical Solution |
Kerydin |
9 July 2018 |
NCE-1 |
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