NEWS FROM USA
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
11 Dec 2018 |
Itraconazole Capsule (505 (b) 2 NDA) |
Mayne |
Tolsura |
|
|
14 Dec 2018 |
Prucalopride Tablets |
Shire |
Motegrity |
505(b)2 IN PIPELINE:
Diroximel fumarate (Alkermes/Biogen): Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Mesalamine DR Tablets |
Mylan |
Lialda (Shire) |
$842 Million |
|
|
Mesalamine Rectal Suppository |
Mylan |
Canasa (Allergan) |
$263 Million |
Highlighted product is the 1st Generic launch
UPDATES ON BIOSIMILARS (USA)
Infliximab biosimilar (Amgen): Amgen Submits Biologics License Application for ABP 710 (Biosimilar Infliximab) to USFDA
Trastuzumab biosimilar (Celltrion): Celltrion and Teva Announce FDA Approval of HERZUMA® (trastuzumab-pkrb), a Biosimilar to HERCEPTIN®, for the Treatment of HER2-Overexpressing Breast Cancer for Certain Indications
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
12 Dec 2018 |
Lidocaine Ointment |
G AND W LABS INC |
N/A |
Twelve |
|
17 Dec 2018 |
Glenmark |
Westcort (Sun Pharma) |
Two (Perrigo, Taro) |
|
|
17 Dec 2018 |
Lupin |
Onfi Tablets (Lundbeck) |
Nine |
*Highlighted product has received Competitive Generic Therapy designation
TENTATIVE ANDA APPROVALS
|
Approval Date |
Drug |
Company |
|
13 Dec 2018 |
Actavis |
|
|
13 Dec 2018 |
Ajanta |
|
|
14 Dec 2018 |
Zydus |
|
|
17 Dec 2018 |
Lupin |
USFDA INSPECTIONS
Biocon's APIs Manufacturing Facility in Telangana Completes U.S. FDA Inspection
Solara
Research Centre completes USFDA Inspection with Zero observation
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