New Indications and Dosage Forms for 2018
See also: New Drug Approvals for 2018
January 5, 2018
January 11, 2018
January 12, 2018
January 16, 2018
January 25, 2018
February 1, 2018
February 5, 2018
February 8, 2018
February 14, 2018
February 16, 2018
February 22, 2018
February 26, 2018
March 2, 2018
March 6, 2018
- Bristol-Myers Squibb’s Opdivo (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing
- FDA Approves Latuda (lurasidone HCl) for Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)
March 16, 2018
March 20, 2018
March 21, 2018
March 22, 2018
March 27, 2018
March 29, 2018
April 3, 2018
April 6, 2018
- Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
- Pacira Announces FDA Approval of Exparel as a Nerve Block to Produce Regional Analgesia
April 12, 2018
April 16, 2018
April 17, 2018
- FDA Approves Vonvendi [von Willebrand factor (recombinant)] for Perioperative Management of Bleeding in Adult Patients with von Willebrand Disease
- FDA Provides Full Approval to Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa
April 18, 2018
April 30, 2018
May 1, 2018
May 4, 2018
May 7, 2018
- FDA Approves Darzalex (daratumumab) for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible
- FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with Solifenacin Succinate for the Treatment of Overactive Bladder Symptoms
May 11, 2018
May 14, 2018
- FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis
- UCB Announces Briviact (brivaracetam) Now Approved by FDA to Treat Partial-Onset (Focal) Seizures in Pediatric Epilepsy Patients
May 15, 2018
May 21, 2018
May 22, 2018
May 24, 2018
May 28, 2018
May 30, 2018
June 7, 2018
- FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
- FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris
June 8, 2018
June 12, 2018
June 13, 2018
- FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
- FDA Approves Genentech’s Avastin (bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery
June 21, 2018
June 29, 2018
July 2, 2018
July 3, 2018
July 11, 2018
July 13, 2018
July 18, 2018
July 31, 2018
August 6, 2018
August 7, 2018
August 15, 2018
August 16, 2018
August 17, 2018
- FDA Approves Opdivo (nivolumab) for Certain Patients with Previously Treated Small Cell Lung Cancer
- FDA Approves New Eylea (aflibercept) Injection Dosing Schedule in Wet Age-Related Macular Degeneration
August 21, 2018
August 27, 2018
September 13, 2018
September 27, 2018
September 28, 2018
- FDA Approves Fycompa for the Treatment of Partial-Onset Seizures in Pediatric Patients as Young as 4 Years Old
- FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation
October 1, 2018
October 4, 2018
October 5, 2018
- FDA Approves Expanded Use of Gardasil 9 to Include Individuals 27 Through 45 Years Old
- FDA Approves Accelerated 7-Day Vaccine Dosing Schedule for Ixiaro
October 11, 2018
October 16, 2018
October 19, 2018
October 23, 2018
October 30, 2018
- FDA Approves Invokana (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
- FDA Approves Keytruda (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
November 6, 2018
November 9, 2018
November 16, 2018
- FDA Approves Promacta (eltrombopag) for First-Line Severe Aplastic Anemia
- FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas
November 21, 2018
November 26, 2018
December 6, 2018
December 14, 2018
December 19, 2018
- FDA Approves New Indication for Envarsus XR (tacrolimus extended-release tablets)
- Lynparza (olaparib) Approved by US FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer
- FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma