NEWS FROM USA
New Paragraph IV filing
|
DRUG |
Dosage form |
Corresponding RLD |
Date of Submission |
Type of Submission (Based on Date) |
|
Ibrutinib (140 And 560 Mg) |
Tablets |
Imbruvica |
05 Nov 2018 |
Post NCE-1 Submission For New Dosage Form |
|
Ibrutinib (280 And 420 Mg) |
Tablets |
Imbruvica |
14 Dec 2018 |
Post NCE-1 Submission For New Dosage Form |
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
28 Jan 2019 |
Sumatriptan Nasal Spray |
Dr Reddys |
Tosymra |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
25 Jan 2019 |
Actavis |
Aleve Pm (Bayer) |
One (Amneal) |
|
|
25 Jan 2019 |
Hainan Poly |
Integrilin (Schering) |
Eight |
|
|
25 Jan 2019 |
Fresenius |
Bentyl (Allergan) |
Six |
|
|
25 Jan 2019 |
Dr Reddys |
Fluoxetine Hydrochloride (Alvogen) |
Five |
|
|
25 Jan 2019 |
Alkem |
Zanaflex (Covis) |
Eleven |
|
|
25 Jan 2019 |
Sun Pharma |
Lialda (Shire) |
Three |
|
|
28 Jan 2019 |
Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate Injection |
Fresenius |
Lactated Ringer's In Plastic Container (Baxter) |
Two (B Braun, Icu Medical) |
|
28 Jan 2019 |
Encube |
Cleocin T (Pharmacia And Upjohn) |
Ten |
|
|
28 Jan 2019 |
Cipla |
Depo-Provera (Pfizer) |
Five |
|
|
28 Jan 2019 |
Abhai |
Ddavp (Ferring) |
Six |
|
|
28 Jan 2019 |
Graviti |
Wellbutrin Xl (Valeant) |
Seventeen |
|
|
28 Jan 2019 |
(1%) |
Fougera |
N/A |
None |
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
22 Jan 2019 |
Glenmark |
|
|
25 Jan 2019 |
Celerity Pharms |
|
|
25 Jan 2019 |
Sun Pharma |
|
|
28 Jan 2019 |
MSN Labs |
|
|
28 Jan 2019 |
Alkem Labs |
|
|
29 Jan 2019 |
Alkem Labs |
USFDA Inspections
Dishman gets EIR for its Bavla plant
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