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Week of May 3, 2021

13

May 3, 2021approval1947d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: DR REDDYS LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

May 4, 2021approval1946d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

May 4, 2021approval1946d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

May 4, 2021approval1946d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

May 4, 2021approval1946d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

May 4, 2021approval1946d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

May 5, 2021approval1945d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

May 6, 2021approval1944d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

Sponsor: ALKERMES. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →naltrexone ER →fda approvals ↗

May 6, 2021approval1944d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →IRBESARTAN →fda approvals ↗

May 6, 2021approval1944d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →IRBESARTAN →fda approvals ↗

May 7, 2021approval1943d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

May 7, 2021approval1943d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

May 7, 2021approval1943d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of May 10, 2021

13

May 11, 2021approval1939d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗

May 11, 2021approval1939d agoDIPRIVAN (PROPOFOL) — FDA approvalPROPOFOL

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →PROPOFOL →fda approvals ↗

May 12, 2021approval1938d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

May 12, 2021approval1938d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

May 12, 2021approval1938d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

May 12, 2021approval1938d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

May 12, 2021approval1938d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

May 12, 2021approval1938d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

May 13, 2021approval1937d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: DEXCEL. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

May 14, 2021approval1936d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

May 14, 2021approval1936d agoMIFEPREX (MIFEPRISTONE) — FDA approvalCORCEPT THERAPEUTICS INC

Sponsor: DANCO LABS LLC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

May 14, 2021approval1936d agoMIFEPRISTONE — FDA approvalMIFEPRISTONE

Sponsor: GENBIOPRO. Form: TABLET. Route: ORAL

full page →MIFEPRISTONE →fda approvals ↗

May 16, 2021approval1934d agoGLIPIZIDE — FDA approvalGreenstone LLC

Sponsor: WATSON LABS TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of May 24, 2021

12

May 24, 2021approval1926d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: TABLET. Route: ORAL

full page →enzalutamide →fda approvals ↗

May 25, 2021approval1925d agoCAMCEVI KIT (LEUPROLIDE MESYLATE) — FDA approvalForesee Pharmaceuticals Co Ltd

Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS

full page →fda approvals ↗

May 27, 2021approval1923d agoNURTEC ODT (RIMEGEPANT SULFATE) — FDA approvalrimegepant sulfate ODT

Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →rimegepant sulfate ODT →fda approvals ↗

May 27, 2021approval1923d agoJUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

May 27, 2021approval1923d agoATORVASTATIN CALCIUM — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

May 27, 2021approval1923d agoATORVASTATIN CALCIUM — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

May 27, 2021approval1923d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

May 27, 2021approval1923d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

full page →methylprednisolone sodium succinate →fda approvals ↗

May 28, 2021approval1922d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

May 28, 2021approval1922d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL

full page →(olanzapine + samidorphan l-malate) →fda approvals ↗

May 28, 2021approval1922d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL

full page →(olanzapine + samidorphan l-malate) →fda approvals ↗

May 28, 2021approval1922d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL

full page →fda approvals ↗