Insights+: The US FDA New Drug Approvals in 2018

1. Janssen’s Erleada (apalutamide) Receives FDA Approval for Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)

Published: 14 Feb,2018 | Tags: Janssen, Erleada, apalutamide, Receives, FDA, Approval, Non-Metastatic Castration-Resistant Prostate Cancer, NM-CRPC

2. Helsinn’s (fosnetupitant + palonosetron) Receives FDA Approval for Managing Chemotherapy-Induced Nausea and Vomiting (CINV)

Published: 14 Feb,2018 | Tags: Helsins, fosnetupitant + palonosetron, Receives, FDA, Approval, Managing Chemotherapy-Induced Nausea and Vomiting, CINV

3. Servier’s Asparlas (calaspargase pegol-mknl) Receives FDA’s Approval for Acute Lymphoblastic Leukemia (ALL)

Published: 01 Mar,2018 | Tags: Servier, Asparlas, calaspargase pegol-mknl, Receives, FDA, Approval, Acute Lymphoblastic Leukemia, ALL

4. TaiMed Biologics Trogarzo (ibalizumab-uiyk) Receives Approval for Multidrug Resistant (MDR)-HIV

Published: 06 Mar,2018 | Tags: TaiMed Biologics, Trogarzo, ibalizumab-uiyk, Receives, Approval, Multidrug Resistant, MDR-H

5. Rigel Pharmaceuticals Tavalisse (fostamatinib disodium hexahydrate) Receives FDA Approval for Chronic Immune Thrombocytopenia (ITP) in Adults

Published: 06 Mar,2018 | Tags: Rigel Pharmaceuticals, Tavalisse, fostamatinib disodium hexahydrate, Receives, FDA, Approval, Chronic Immune Thrombocytopenia, ITP, Adults

6. Amgen’s Aimovig (erenumab-aooe) Receives FDA’s Approval for Prevention of Migraine in Adults

Published: 17 May,2018 | Tags: Amgen, Aimovig, erenumab-aooe, Receives, FDA, Approval, Prevention, Migraine, Adults

7. AstraZeneca’s Lokelma Receives FDA’s Approval for Patients with Hyperkalaemia in Adults

Published: 18 May,2018 | Tags: AstraZeneca, Lokelma, Receives, FDA, Approval, Patients, Hyperkalaemia, Adults

8. BioMarin’s Palynziq (pegvaliase-pqpz) Receives FDA Approval for Phenylketonuria (PKU) in Adults

Published: 24 May,2018 | Tags: BioMarin, Palynziq, pegvaliase-pqpz, Receives, FDA, Approval, Phenylketonuria, PKU, Adults

9. Medicines Development for Global Health’s (MDGH) Moxidectin Receives FDA Approval for Onchocerciasis (River Blindness)

Published: 13 Jun,2018 | Tags: Medicines Development for Global Health, MDGH, Moxidectin, Receives, FDA, Approval, Onchocerciasis, River Blindness

10. GSK’s Krintafel (tafenoquine) Receives FDA Approval Preventing the Relapse of P.vivax Malaria

Published: 20 Jun,2018 | Tags: GSK, Krintafel, tafenoquine, Received, FDA, approval, Preventing, Relapse , P.vivax Malaria

11. GW Pharmaceuticals Epidiolex (cannabidiol) Receives FDA Approval for Epilepsy for 2yrs. or older

Published: 25 Jun,2018 | Tags: GW Pharmaceuticals, Epidiolex, cannabidiol, Receives, FDA, Approval, Epilepsy, 2yrs, older

12. Agios Pharmaceuticals Tibsovo (ivosidenib) Receives Approval For R/R Acute Myeloid Leukemia (AML) and IDH1 Mutation

Published: 26 Jun,2018 | Tags: Agios Pharmaceuticals, Tibsovo, ivosidenib, Receives, Approval, R/R, Acute Myeloid Leukemia, AML, IDH1 Mutation

13. Achaogen’s Zemdri (plazomicin) Receives FDA Approval for Complicated Urinary Tract Infection (cUTI)

Published: 26 Jun,2018 | Tags: Achaogen, Zemdri, plazomicin, Receives, FDA, Approval, Complicated Urinary Tract Infection, cUTI

14. SIGA Technologies TPOXX (tecovirimat) Receives FDA Approval for Smallpox

Published: 26 Jun,2018 | Tags: SIGA Technologies, TPOXX, tecovirimat, Receives, FDA, Approval, Smallpox

15. Shionogi’s Mulpleta (lusutrombopag) Receives FDA Approval for Chronic Liver Patients in Adults

Published: 31 July,2018 | Tags: Shionogi, Mulpleta, lusutrombopag, Receives, FDA, Approval, Chronic Liver, Patients, Adults

16. FDA approves IV Poteligeo for Treating Two Rare types of Cutaneous T cell lymphoma (CTCL)

Published: 08 Aug,2018 | Tags: FDA, approves, IV, Poteligeo, Treating, Two, Rare, types, Cutaneous, T cell, lymphoma, CTCL

17. Therapeutics MD’s Annovera (Segesterone Acetate/Ethinyl Estradiol) Receives FDA Approval for the Prevention of Pregnancy

Published: 10 Aug,2018 | Tags: Therapeutics MD, Annovera, Segesterone Acetate/Ethinyl Estradiol, Receives, FDA, Approval, Prevention, Pregnancy

18. Amicus Therapeutics Galafold (migalastat) Receives FDA Approval for Fabry Disease in Adult Patient

Published: 10 Aug,2018 | Tags: Amicus Therapeutics, Galafold, migalastat, Receives, FDA, Approval, Fabry Disease, Adult Patients

19. FDA Approves Onpattro, a Novel RNAi Therapeutic to Treat Polyneuropathy in Adults  

Published: 13 Aug,2018 | Tags: FDA, Approves, Onpattro, Novel, RNAi, Therapeutic, Treat, Polyneuropathy, Adults

20. Biocodex’s Diacomit (stiripentol) Receives FDA Approval for Seizures Associated with Dravet Syndrome (DS) in Patients Aged 2 Years or Older

Published: 23 Aug,2018 | Tags: Biocodex, Diacomit, stiripentol, Receives, FDA, Approval, Seizures, Associated, Dravet Syndrome, DS, Patients, Aged 2 Years ,Older

21.Shire’s Takhzyro (lanadelumab-flyo) Receives FDA Approval Novel Hereditary Angioedema (HAE) in Age =12yrs

Published: 24 Aug,2018 | Tags: Shire, Takhzyro, lanadelumab-flyo, Receives, FDA, Approval, Novel, Hereditary Angioedema, HAE, Age, =12yrs

22. Lilly Receives FDA Approval for Emgality (galcanezumab-gnlm) for Preventive Treatment of Migraine in Adults

Published: 27 Aug,2018 | Tags: Eli Lilly, Receives, FDA, Approval, Emgality, galcanezumab-gnlm, Preventive, Treatment, Migraine, Adults

23. Tetraphase Pharmaceuticals Xerava (eravacycline) Receives FDA’s Approval for Complicated Intra-Abdominal Infections (CIAI)

Published: 27 Aug,2018 | Tags: Tetraphase Pharmaceuticals, Xerava, eravacycline , Receives, FDA, Approval, Complicated Intra-Abdominal Infections, CIAI

24. Merck’s Pifeltro (doravirine) Receives FDA Approval for Patients with HIV-1 in Appropriate Patients

Published: 14 Sep,2018 | Tags: Merck, Pifeltro, doravirine, Receives, FDA, Approval, Patients, HIV-1, Appropriate Patients

25. AstraZeneca’s Lumoxiti Receives FDA approval for the Treatment of R/R 2L+ Hairy Cell Leukemia in patients

Published: 14 Sep,2018 | Tags: AstraZeneca, Lumoxiti, Receives, FDA, Approval, for the Treatment of R/R 2L+ Hairy Cell Leukemia in patients

26. Teva’s Receives FDA Approval for the Treatment of Migraine in Adults with Monthly and Quarterly Dosing

Published: 17 Sep,2018 | Tags: Teva, Receives, FDA, Approval, Treatment, Migraine, Adults, Monthly, Quarterly Dosing

27. Verastem Oncology’s Copiktra (duvelisib) Receives FDA Approval for r/r 2L+ Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Published: 24 Sep,2018 | Tags: Verastem Oncology, Copiktra, duvelisib, Receives, FDA, Approval, R/R, 2L+, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, CLL

28. Pfizer’s Vizimpro (Dacomitinib) Receives the US FDA Approval for 1L Treatment of mNSCLC with Epidermal Growth Factor Receptor (EGFR)

Published: 27 Sep,2018 | Tags: Pfizer, Vizimpro, Dacomitinib, Receives, the US FDA, Approval, 1L, Treatment, mNSCLC, Epidermal Growth Factor Receptor,EGFR

29. Sanofi’s Libtayo Receives the US FDA approval for Metastatic Cutaneous Squamous Cell Carcinoma (mCSCC)

Published: 28 Sep,2018 | Tags: Sanofi, Libtayo, Receives, the US FDA, Approval, Metastatic Cutaneous Squamous Cell Carcinoma, mCSCC

30. Paratek’s Seysara (sarecycline) Receives FDA’s Approval for Treatment of Moderate to Severe Acne

Published: 02 Oct,2018 | Tags: Paratek, Seysara, sarecycline, Receives, FDA, Approval, Treatment, Moderate to Severe, Acne

31. Paratek Pharmaceuticals’ Nuzyra (omadacycline) Receives FDA Approval for Community-Acquired Bacterial Pneumonia (CABP) and Acute Skin and Skin Structure Infections (ABSSSI) in Adults

Published: 05 Oct,2018 | Tags: Paratek Pharmaceuticals, Nuzyra, omadacycline, Receives, FDA, Approval, Community-Acquired Bacterial Pneumonia, CABP, Acute Skin Skin Structure Infections,ABSSSI, Adult

32. Ionis Tegsedi (inotersen) Receives FDA Approval for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults

Published: 05 Oct,2018 | Tags: Ionis, Tegsedi, inotersen, Receives, FDA, Approval, Polyneuropathy, Hereditary Transthyretin-Mediated Amyloidosis, Adults

 33. Leadiant Biosciences Revcovi’s (elapegademase-lvlr) Receives FDA Approval for Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID) in Pediatric and Adult Patients

Published: 05 Oct,2018 | Tags: Leadiant Biosciences, Revcovi, (elapegademase-lvlr), Receives, FDA, Approval, Adenosine, Deaminase Severe Combined Immune Deficiency, (ADA-SCID), Pediatric, Adult, Patients

34. Eli Lilly’s Olumiant (baricitinib) Receives FDA Approval for Moderately-to-Severely Active Rheumatoid Arthritis (RA) in Adults

Published: 08 Oct,2018 | Tags: Eli Lilly, Olumiant, baricitinib, Receives, FDA, Approval, Moderately-to-Severely, Active, Rheumatoid Arthritis, RA, Adult

35. AbbVie’s Orilissa (elagolix) Receives Health Canada Approval to Treat Moderate-to-Severe Pain Associated with Endometriosis

Published: 08 Oct,2018 | Tags: AbbVie, Orilissa (elagolix) Receives FDA’s Approval for Moderate-to-Severe Pain Associated with Endometriosis

36. Pfizer’s Talzenna (talazoparib) Receives FDA Approval for BRCA-Mutated, HER2-Negative LA or MBC

Published: 11 Oct,2018 | Tags: Pfizer, Talzenna, (talazoparib), Receives, FDA ,Approval,  BRCA-Mutated, HER2-Negative, LA , MBC

37. Pfizer’s Daurismo (glasdegib) Receives FDA Approval for Adults with Newly-Diagnosed Acute Myeloid Leukemia (AML)

Published: 11 Oct,2018 | Tags: Pfizer, Daurismo, glasdegib, Receives, FDA, Approval, Adults, Newly-Diagnosed, Acute Myeloid Leukemia, AML

38. Catalyst’s Firdapse (amifampridine) Receives FDA’s Approval for Lambert-Eaton Myasthenic Syndrome

Published: 20 Oct,2018 | Tags: Catalyst, Firdapse, amifampridine, Receives, FDA, Approval, Lambert-Eaton Myasthenic Syndrome

39. Roche’s Xofluza (baloxavir marboxil) Receives FDA Approval for Influenza in Patients Aged ≥12 yrs.

Published: 25 Oct,2018 | Tags: Roche, Xofluza, baloxavir marboxil,  Receives, FDA, Approval, Influenza, Patients, Aged, ≥12 yrs.

40. Sobi’s Gamifant (emapalumab) Receives FDA Approval for Primary Haemophagocytic Lymphohistiocytosis (HLH

Published: 10 Nov,2018 | Tags: Sobi, Gamifant, emapalumab, Receives, FDA, Approval, Primary Haemophagocytic Lymphohistiocytosis, HLH

41. Astellas’ Xospata (gilteritinib) Receives FDA ‘s Approval for 1L R/R Acute Myeloid Leukemia (AML) in Adults

Published: 30 Nov,2018 | Tags: Astellas, Xospata, gilteritinib, Receives, FDA ‘s, Approval, Treatment, Relapsed/Refactory Acute Myeloid Leukemia, (AML), Adults

42. Pfizer’s Lorbrena (lorlatinib) Receives FDA Approval for Patients with 1L ALK- Positive Metastatic NSCL

Published: 20 Nov,2018 | Tags: Pfizer, Lorbrena,lorlatinib, Receives, FDA, Approval, Patients, 1L, ALK, Positive, Metastatic, NSCLC

43. Shire’s Motegrity (prucalopride) Receives FDA Approval for Chronic Idiopathic Constipation (CIC) in Adults

Published: 17 Dec,2018 | Tags: Shire, Motegrity, prucalopride, Receives, FDA, Approval, Chronic Idiopathic Constipation, CIC, Adults

44. Alexion’s Ultomiris (Ravulizumab-Cwvz) Receives FDA Approval for Paroxysmal Nocturnal Hemoglobinuria (PNH) in Adult

Published: 27 Dec,2018 | Tags: Alexion, Ultomiris, Ravulizumab-Cwvz, Receives, FDA, Approval, Paroxysmal Nocturnal Hemoglobinuria, PNH, Adults

45. FDA Approves Elzonris (tagraxofusp), the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy

Published: 31 Dec,2018 | Tags: FDA, Approves, Elzonris, tagraxofusp, First, Treatment, Blastic Plasmacytoid Dendritic Cell Neoplasm, First, CD123-Targeted, Therapy