Calendar

pharmadog

Week of May 15, 2017

May 15, 2017approval3395d agoALLI (ORLISTAT) — FDA approvalH2-Pharma LLC

Sponsor: HALEON US HOLDINGS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

May 16, 2017approval3394d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

full page →vandetanib →fda approvals ↗

May 17, 2017approval3393d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

May 17, 2017approval3393d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

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May 17, 2017approval3393d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

full page →ivacaftor →fda approvals ↗

May 18, 2017approval3392d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

May 18, 2017approval3392d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

May 18, 2017approval3392d agoYONDELIS (TRABECTEDIN) — FDA approvalJOHNSON & JOHNSON

Sponsor: JANSSEN PRODS. Form: POWDER. Route: INTRAVENOUS

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May 19, 2017approval3391d agoIMPLANON (ETONOGESTREL) — FDA approvaletonogestrel CR

Sponsor: ORGANON. Form: IMPLANT. Route: IMPLANTATION

full page →etonogestrel CR →fda approvals ↗

May 19, 2017approval3391d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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May 19, 2017approval3391d agoSYNAREL (NAFARELIN ACETATE) — FDA approvalnafarelin acetate

Sponsor: PFIZER. Form: SPRAY, METERED. Route: NASAL

full page →nafarelin acetate →fda approvals ↗

May 19, 2017approval3391d agoSYNAREL (NAFARELIN ACETATE) — FDA approvalnafarelin acetate

Sponsor: PFIZER. Form: SPRAY, METERED. Route: NASAL

full page →nafarelin acetate →fda approvals ↗

May 19, 2017approval3391d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

May 19, 2017approval3391d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: ABBVIE ENDOCRINE INC. Form: SOLUTION. Route: SUBCUTANEOUS

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May 19, 2017approval3391d agoDEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) — FDA approvalMallinckrodt LLC

Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

May 19, 2017approval3391d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: SUN PHARM. Form: SOLUTION. Route: SUBCUTANEOUS

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May 19, 2017approval3391d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: SUN PHARM. Form: SOLUTION. Route: SUBCUTANEOUS

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May 19, 2017approval3391d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

May 19, 2017approval3391d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

May 19, 2017approval3391d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

May 19, 2017approval3391d agoSUPPRELIN LA (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

full page →fda approvals ↗

May 19, 2017approval3391d agoSUPPRELIN LA (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

full page →fda approvals ↗

May 19, 2017approval3391d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

May 19, 2017approval3391d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

May 19, 2017approval3391d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

May 19, 2017approval3391d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Week of May 22, 2017

May 22, 2017approval3388d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

May 22, 2017approval3388d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

May 22, 2017approval3388d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗

May 22, 2017approval3388d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →tocilizumab →fda approvals ↗

May 23, 2017approval3387d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 23, 2017approval3387d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: LANNETT CO INC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 23, 2017approval3387d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

May 25, 2017approval3385d agoSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (SODIUM CHLORIDE) — FDA approvalRevalesio Corp

Sponsor: LABORATORIOS GRIFOLS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of May 8, 2017

Week of May 15, 2017

Week of May 22, 2017