NEWS FROM USA
NEW GENERICS LAUNCHES IN US
|
LAUNCH DATE |
DRUG |
Marketer |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
24 July 2049 |
Ramelteon Tablets |
Zydus |
Rozerem (Takeda Pharma) |
$91.3 Million |
|
|
23 July 2019 |
Dr. Reddy’s laboratories (DRL) |
||||
|
22 July 2019 |
Pregabalin capsules |
Amneal |
Lyrica (PF Prism) |
$5.4 Million |
|
|
19 July 2019 |
Busulfan |
Apotex Pharma |
Busulfex (Otsuka pharma) |
N/A |
NDA APPROVALS
New formulation approvals
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Comments |
|
24 July 2019 |
Glucagon inhalation powder |
Eli lilly |
Baqsimi |
Previously Glucagon was available only as injectable formulation.
Baqsimi is the first glucagon therapy approved for the emergency treatment of the condition, without using an injection.
|
|
19 July 2019 |
Duloxetine DR sprinkle Capsules (505(b)2) |
Sun Pharma |
Drizalma sprinkle |
Currently marketed Duloxetine is available as delayed release capsule that is required to be taken as whole, while Drizalma Sprinkle may be opened and sprinkled over applesauce; or administered via nasogastric tube.
|
|
25 July 2019 |
Bivalirudin Ready-to-use solution (505(b)2) |
Maia pharma |
Angiomax RTU |
Currently Bivalirudin is available as lyophilized powder and premix solution (250mg/50ml; 500mg/100ml). Bivalirudin premix solution is marketed by Baxter in their Galaxy plastic container which is stored at frozen temperature.
Angiomax RTU also contains the same strength (250mg/50ml) that is marketed by Baxter.
|
New molecular entity approval
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Comments |
|
25 July 2019 |
Ferric maltol capsules |
Shield UK |
Accrufer |
Iron replacement product approved for the treatment of iron deficiency in adults. This product is already approved in European union and Switzerland.
|
ANDA APPROVALS
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
17 July 2019 |
Nesher Pharma |
Adderall XR 5 (Shire) |
Nine |
|
|
17 July 2019 |
Caplin |
Cyklokapron (Pharmacia And Upjohn) |
More Than 10 |
|
|
17 July 2019 |
Apollo Pharma |
|||
|
18 July 2019 |
Umedica Labs |
Benicar (Daiichi Sankyo) |
More Than 10 |
|
|
18 July 2019 |
Graviti Pharma |
Trilipix (Abbvie) |
Six |
|
|
19 July 2019 |
Alkem Labs |
Focalin (Novartis) |
Six |
|
|
19 July 2019 |
Teva Alembic Alkem |
Lyrica (PF Prism) |
Eight |
|
|
19 July 2019 |
(20 mg/ml) |
Alkem Labs |
Lyrica (PF Prism) |
None |
|
22 July 2019 |
Upsher Smith |
Morphine Sulfate (Hikma) |
None |
|
|
22 July 2019 |
Zydus Pharms |
Rozerem (Takeda) |
Two (Actavis, Dr Reddys) |
|
|
23 July 2019 |
Sun Pharm |
Yaz (Bayer Hlthcare) |
More Than 10 |
|
|
23 July 2019 |
Mylan |
Faslodex (Astrazeneca) |
Two (Amneal, Sandoz) |
|
|
24 July 2019 |
Torrent |
N/A |
Seven |
Highlighted product was mentioned in FDA’s off-patent off-exclusivity products without an approved generic list.
TENTATIVE ANDA APPROVALS
|
Approval Date |
Drug |
Company |
|
17 July 2019 |
Sandoz |
|
|
19 July 2019 |
Sun Pharma |
|
|
19 July 2019 |
Alembic Pharms |
|
|
19 July 2019 |
Amneal Pharms |
OTHER NEWS FROM THE USA
Pfizer nears deal to combine Off-Patent drug business With Mylan.
Full story: Wallstreet Journal
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