NEWS FROM USA
ANDA Approvals
|
DRUG |
COMPANY |
Corresponding RLD |
Press release if available |
|
Colesevelam Hydrochloride For Oral Suspension |
Glenmark |
Welchol (Daiichi sankyo) |
|
|
Clindamycin Phosphate Topical Solution |
Zydus |
Cleocin T (Pharmacia) |
|
|
Caspofungin Acetate Injectable |
Cipla |
Cancidas (Merck) |
|
|
Oxytocin Injectable |
Sagent |
Oxytocin (Fresenius Kabi ) |
|
|
Busulfan Injectable |
Mylan |
Busulfex (Otsuka Pharm) |
|
|
Imatinib Mesylate Tablets |
West-Ward |
Gleevec (Novartis) |
|
|
Mometasone Furoate Topical Ointment |
Torrent |
Elocon (Merck Sharp ) |
|
|
Roflumilast Tablets |
Mylan |
Daliresp (Astrazeneca ) |
|
|
Verapamil Hydrochloride IV |
Amneal |
N/A |
|
New Inter Partes Review petitions filed
|
DRUG |
Innovator |
Petitioner |
Patents challenged (Petition No.) |
|
Dimethyl fumarate |
Biogen |
Mylan |
8,399,514 (IPR2018-01403) |
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