The first artificial iris, cannabis-derived drug and more: 73 FDA approvals in 2018

The FDA has signed off on many innovative medical devices, software platforms and drug therapies this year that aim to improve patient care.

Here are 73 FDA approvals or market clearances Becker's has reported in 2018, as of July 19. Approvals are organized by product type.

Note: This may not be an exhaustive list of every FDA approval in 2018.


1. A combination of Bristol-Myers Squibb's cancer drugs Opdivo and Yervoy may now be used to treat a specific form of metastatic colorectal cancer.

2. Epidiolex is the first cannabis-based drug approved to treat seizures linked to Lennox-Gastaut syndrome or Dravet syndrome.

3. Braftovi and Mektov iis a combination therapy used to treat advanced melanoma in patients with a specific gene mutation.

4. Diflorasone diacetate ointment is a topical steroid used to treat pain, itching and swelling caused by skin diseases.

5. Moxidectin is a treatment for onchocerciasis, also known as river blindness, which is a skin and eye disease caused by a parasitic worm.

6. Buprenorphine and naloxone sublingual film is the first generic version of Suboxone used to treat opioid dependence.

7. Keytruda may now be used to treat patients with recurrent or metastatic cervical cancer.

8. Keytruda also gained approval to treat adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma.

9. Mylan's drug Fulphila represents the first biosimilar version of Amgen's Neulasta, both of which boost white blood cell count to reduce infection risk in cancer patients undergoing chemotherapy.

10. Rituxan is the first treatment approved for moderate-to-severe pemphigus vulgaris, a rare autoimmune disease characterized by painful blistering on the skin and mucous membranes.

11. Mircera may now be used to treat chronic kidney disease-associated anemia in children.

12. Palynziq is an enzyme substitution therapy for adults with the rare inherited disorder phenylketonuria.

13. Imvexxy is a hormone therapy for a vaginal condition linked to low estrogen levels during menopause.

14. Xeljanz may now be used to treat adults with moderate-to-severe ulcerative colitis.

15. Gilenya, a disease-modifying therapy, may now be used to treat children 10 and up with multiple sclerosis.

16. Lucemyra is the first nonopioid treatment for adults managing opioid withdrawal symptoms.

17. Retacrit is a biosimilar version of the anemia therapy Epogen/Procrit.

18. Lokelma is intended to treat patients with hyperkalemia, a condition involving elevated potassium levels in the blood.

19. Doptelet is used to treat thrombocytopenia — a condition involving a low blood platelet count — in chronic liver disease patients set to undergo a medical or dental procedure.

20. Plenvu is a liquid drug patients can drink to cleanse their bowels before a colonoscopy.

21. Novartis' combination therapyof Tafinlar and Mekinist may now be used to treat an aggressive form of thyroid cancer.

22. Kymriah may now be used to treat patients with large B-cell lymphoma whose cancer has progressed after at least two previous therapies.

23. Crysvita is the first drug approved to treat x-linked hypophosphatemia — a rare, inherited form of rickets.

24. Tagrisso may now be used as a first-line treatment for patients with metastatic non-small cell lung cancer with a specific genetic mutation.

25. Adcetris is the first new frontline treatment for advanced Hodgkin lymphoma in 40 years.

26. Lucentis is available as a 0.3 milligram prefilled syringe to treat diabetic macular edema and diabetic retinopathy.

27. Hizentra is the first subcutaneous immunoglobulin approved to treat chronic inflammatory demyelinating polyneuropathy, a rare autoimmune disorder that affects the peripheral nerves.

28. Trogarzo is an antiretroviral medication for adult HIV patients who do not respond to other HIV therapies on the market.

29. Verzenio, in combination with an aromatase inhibitor, is a treatment for advanced or metastatic breast cancer in postmenopausal women.

30. Imfinzi is used to treat patients with inoperable, midstage non-small cell lung cancer that has not metastasized throughout the body.

31. Osmolex may be used to treat patients with Parkinson's disease or drug-induced movement disorders.

32. Erleada is used to treat nonmetastatic prostate cancer that does not respond to hormone therapy.

33. Betamethasone dipropionate is a topical steroid used to treat itching and other skin conditions, like eczema.

34. Glatopa is used to treat patients with relapsing forms of multiple sclerosis.

35. Feraheme may now be used to treat adults with iron deficiency anemia who do not respond to or are intolerant to oral iron.

36. Biktarvy is a once-daily, triple-combination tablet used to treat HIV infections.

37. Firvanq is a vancomycin hydrochloride oral solution used to treat Clostridium difficile-associated diarrhea and Staphylococcus aureus-associated intestinal inflammation.

38. Lutathera is a radioactive drug that treats gastroenteropancreatic neuroendocrine tumors.

39. Bivalirudin is an anticoagulant intended for patients undergoing percutaneous coronary intervention.

40. Avycaz may now be used to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

41. Lynparza may now be used to treat breast cancer patients with metastasized tumors that carry a specific BRCA gene mutation.

42. Xgeva may now be used to prevent bone fractures in patients with multiple myeloma.

43. Oseltamivir phosphate capsules, a generic form of Roche's Tamiflu, are used to treat uncomplicated influenza A and B.

Medical devices

44. The FDA approved a next generation version of Abbott's MitraClip heart valve repair device, which offers an alternative to open-heart surgery.

45. Medtronic's HeartWare HVAD System is now the only left ventricular assist device approved for implantation via a thoracotomy.

46. The Eversense CGM system is the first continuous glucose monitoring system that includes a fully implantable sensor to detect glucose.

47. CustomFlex Artificial Iris is a surgically implanted device for patients whose iris is missing or damaged.

48. IDx-DR is a medical device that uses artificial intelligence to detect diabetic retinopathy by analyzing images of a patient's eye.

49. TheDexcom G6 is the first fully interoperable continuous glucose monitoring system.

50. The Guardian Connect system is a continuous glucose monitoring device that uses predictive analytics and artificial intelligence technology from IBM Watson Health to analyze glucose levels.

51. The Masters Series Mechanical Heart Valve is now available in a 15 millimeter size for use in newborns with heart defects.

52. The Resolute Onyx 2.0 mm stent, which is the smallest drug-eluding stent available in the U.S. market, can be used to treat coronary blood-vessel blockages.

53. The RadioGenix System produces Technetium-99m — the most common radioisotope used in medical imaging.

54. The Trevo Retriever, a clot-removal device, may now be used as a first-line treatment for stroke patients for up to 24 hours after symptom onset.

Detection tests/Assays

55. 23andMe's direct-to-consumer breast cancer test screens for three specific BRCA1 and BRCA2 breast cancer gene mutations.

56. The Banyan Brain Trauma Indicator is the first blood test in the U.S. to help physicians detect mild traumatic brain injury, or concussions, in adults.

57. Oxford Immunotec's new detection tests screen for Babesia microti— a parasite transmitted via deer ticks — in samples of donated blood.

58. The Bruker MALDI Biotyper CA system may now be used to identify the emerging pathogen Candida auris.

59. The T2Bacteria Panel detects sepsis-causing bacterial pathogens in blood samples.

60. Cerebrotech Visoris a diagnostic device used to assess cerebral fluid volumes in patients undergoing neurological assessment.

61. BacterioScan 216DX transmits a laser through urine samples to detect bacteria associated with urinary tract infections.

62. The Onclarity HPV Assay can detect 14 types of HPV from patient specimens collected for cervical cancer screening or from a Pap smear.

Software and algorithms

63. Contact is a clinical decision support software for stroke care.

64. Advisor Pro is a decision support software for Type 1 diabetes.

65. OsteoDetect is an artificial intelligence algorithm designed to help physicians detect wrist fractures.


66. Qbrexza is a topical cloth used to treat primary axillary hyperhidrosis, or excessive armpit sweating.

67. Vestex is medical apparel made of fluid-repellent fabric to limit clinicians' exposure to microorganisms from blood, body fluids and other potentially infectious material.

68. Hemospray is an aerosolized spray designed to help control bleeding in the gastrointestinal tract.

69. The Attest Super Rapid Biological Indicator System for Steam provides readings on both steam and vaporized hydrogen peroxide biological indicators in 24 minutes.

70. The Advantage Plus Pass-Thru AER is a disinfection system for commonly used endoscopes.

71. Acuvue Oasys contacts with transitions light intelligent technology are the first contact lens to automatically darken amid bright light exposure.

72. Embrace is a smartwatch that uses artificial intelligence to monitor for seizures.

73. ZTlido, a nonopoid painkiller patch, can be used to treat postherpetic neuralgia, a common complication of shingles characterized by burning pain.


The first artificial iris, cannabis-derived drug and more: 73 FDA approvals so far in 2018

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