PDUFA dates for July 2018
|
DATE |
DRUG |
COMPANY |
|
10 July |
Nivolumab in combination with Ipilimumab |
Bristol-Myers Squibb |
|
21 July |
Cocaine Hydrochloride Topical Solution |
Lannett |
|
28 July |
Risperidone monthly depot |
DURECT Corpoation |
|
28 July |
Buprenorphine Sublingual Spray |
INSYS |
|
30 July |
Iobenguane I 131 |
Progenics Pharmaceuticals |
USFDA News
|
COMPANY |
DRUG |
NEWS |
|
Sandoz/Adamis Pharma |
Epinephrine (Symjepi; 505(b)2 of Epipen) |
Adamis Pharmaceuticals Announces Distribution and Commercialization Agreement for Symjepi |
|
Zydus |
Triamterene and Hydrochlorothiazide Tablets |
Zydus receives final approval from the USFDA for Triamterene and Hydrochlorothiazide Tablets USP |
Aurobindo |
Ibuprofen OTC Capsules |
Aurobindo Pharma receives USFDA Approval for Ibuprofen OTC Capsules |
*For browsing official press releases click on the respective news item.
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