NEWS FROM USA
505(b)2 in pipeline:
Teriparatide (Pfenex): Pfenex Inc. submits 505 (b) 2 NDA to USFDA seeking approval of PF708 for the treatment of osteoporosis. This product is submitted as 505(b)2, referencing Eli Lilly and Company’s Forteo (teriparatide) as the Reference Listed Drug. Alvogen is the marketing partner for this product.
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
06 Dec 2018 |
Cipla |
Singulair (Msd Merck) |
Seventeen |
|
|
06 Dec 2018 |
Azithromycin Tablets (600 mg Base) |
Sunshine |
Zithromax (Pfizer) |
Seven |
|
06 Dec 2018 |
Eugia |
Progesterone (Actavis) |
Three |
|
|
07 Dec 2018 |
Puracap |
Drisdol (US Pharm) |
Five |
|
|
07 Dec 2018 |
Azithromycin Tablets (500mg Base) |
Sunshine |
Zithromax (Pfizer) |
Seven |
|
07 Dec 2018 |
Sunshine |
Zithromax (Pfizer) |
Seven |
|
|
07 Dec 2018 |
Alembic |
Patanol (Novartis) |
Eight |
|
|
07 Dec 2018 |
Sungen |
Adderall (Teva) |
Eleven |
|
|
07 Dec 2018 |
Geneyork |
Deltasone |
Six |
|
|
10 Dec 2018 |
SunGen |
Deltasone |
Six |
|
|
11 Dec 2018 |
Strides |
Albenza (Amneal) |
Two |
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Omeprazole DR Tablets |
Dr Reddy |
Prilosec (Astrazeneca) |
$492 Million |
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
11 Dec 2018 |
Tadalafill tablets |
Unichem lab |
|
10 Dec 2018 |
Apixaban Tablets |
Lupin |
USFDA INSPECTION
Lupin: Lupin’s Pithampur Unit-3 (Indore) receives EIR from US FDA
Jubillant: Jubillant provides USFDA inspection update of their Roorkee solid dosage formulation facility
OTHER NEWS FROM THE USA
Cadila Healthcare (Zydus): Cadila healthcare announces first USFDA approval from company’s Liva Pharma facility at Vadodara,India.
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