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Perspective on the Pipeline - FDA Updates

March 22, 2018

erx_blog_POP_Feb 2018 FDA Approvals_Download graphic_v2.jpgEnvisionRx continuously monitors the drug pipeline. Our clinical information team provides a resource for major drug industry news in order to educate and inform our clients as new drugs are approved, generics launch and current medications receive new indications. The following are drug approvals from the Food and Drug Administration (FDA) for February 2018:

bictegravir, emtricitabine and tenofovir alafenamide 

Manufacturer: Gilead Sciences, Inc.
Indication/Use: HIV Infection
Dosage Form: Tablet
Traditional or Specialty: Traditional

Gilead Science announced that the FDA approved Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) on February 7, 2018. This fixed dose combination product contains a new unboosted integrase strand transfer inhibitor, bictegravir with a Descocy (emtracitabine/tenofovir alafenamide) backbone. Biktarvy’s FDA labeled indications include the treatment of HIV-1 infection in adults who have never been treated or to replace an adult patient’s current regimen if they meet specific clinical requirements. 

For more information:


Manufacturer: Icon Bioscience, Inc.
Indication/Use: Postoperative Ocular Inflammation
Dosage Form: Intraocular Suspension
Traditional or Specialty: Traditional

The FDA’s approval of Dexycu (dexamethasone) on February 12, 2018, provides a new treatment option for inflammation after cataract surgery. Cataract surgeons now have the option of a single intraocular injection at the site of action at the conclusion of surgery, eliminating the need for patient administered eye drops.

For more information:

erx_blog_POP_Feb 2018 FDA Approvals_Download graphic_v2.jpgErleada

Manufacturer: Janssen Pharmaceuticals, Inc.
Indication/Use: Prostate Cancer
Dosage Form: Tablet
Traditional or Specialty: Specialty

The FDA announced on February 14, 2018, the approval of Erleada (apalutamide) for the treatment of prostate cancer in patients in which the cancer has not spread (non-metastatic), but is progressing even with hormone therapy. Erleada is the first FDA-approved cancer therapy for these specific patients. By blocking the effect of hormones on the tumor, Erleada can stop the promotion of tumor growth that occurs from the hormones.

For more information:

Osmolex ER
amantadine hydrochloride

Manufacturer: Osmotica Pharmaceutical US LLC
Indication/Use: Parkinson’s disease, Extrapyramidal Reaction
Dosage Form: Extended-Release Tablet
Traditional or Specialty: Specialty

Osmolex ER (amantadine ER), a combination of immediate-release and extended-release amantadine, was approved February 19, 2018 by the FDA to treat drug-induced movement disorders associated with Parkinson’s disease. Osmolex ER should be taken in the morning and provides a controlled release of medication throughout the day. Another extended-release version of amantadine was approved in the fall of 2017, Gocovri™, by Adamas Pharmaceuticals.

For more information: and

ivacaftor/tezacaftor and ivacaftor

Manufacturer: Vertex Pharmaceuticals, Inc.
Indication/Use: Cystic Fibrosis
Dosage Form: Tablet
Traditional or Specialty: Specialty

On February 13, 2018, the FDA approved Symdeko (tezacaftor/ivacaftor and ivacaftor) to treat cystic fibrosis (CF) patients that have two copies of the F580del mutation gene or have one mutation that is responsive to tezacaftor/ivacaftor. The action of Symdeko against certain gene mutations promotes treatment of the underlying cause of CF and demonstrates improvements in lung function with sustained responses up to 48 weeks in clinical trials.

For more information:

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