FDA Drug Approvals
Posted: Aug 11 2016
Each month the FDA approves new medications, and below is a highlight of the most relevant new approvals and/or drugs which have the potential to impact your prescription plan. While the medications below have been evaluated and approved by the FDA, they may not enter the marketplace for several weeks or months. Therefore, pricing information for these medications is typically unavailable at the time of approval.

New Brand Approvals
Drug NameUses/TreatmentPricing InformationOther Information
Viekira XR®
(dasabuvir, ombitasvir, paritaprevir, and ritonavir)
Treatment of adult patients with chronic hepatitis C with genotype 1a or 1b infection. $33,327 per month (AWP)• Drug Information: Viekira XR is used for the treatment of genotype 1b chronic hepatitis C without cirrhosis or compensated cirrhosis, and treatment of genotype 1a chronic hepatitis C without cirrhosis or compensated cirrhosis in combination with ribavirin. Viekira XR® is taken once daily with a meal. Packaging for one month includes 4 smaller cartons to represent each week of therapy, and within those weekly cartons contain smaller daily dose packs. 
• Formulary Management: Viekira XR® will have non-preferred formulary status. 
• BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrakRx’s BIC Specialty Pharmacy Network. 
• Control Trak: Subject to Max Dollar and Max Dose edits.
Xiidra™ (lifitegrast) ophthalmic solutionTreatment of the signs and symptoms of dry eye disease (DED).$512 per month (AWP)• Drug Information: Xiidra™ is lifitegrast 5% ophthalmic solution used twice daily to treat symptoms of dry eye disease (DED).  Lifitegrast is the first medication in the new class of drugs, called lymphocyte function-associated antigen 1 antagonists (LFA-1 antagonists). Contact lenses should be removed prior to applying the solution and may be re-inserted 15 minutes following application of solution. Common side effects include eye irritation, discomfort, blurred vision and unusual taste sensation.
• Formulary Management: Considered non-preferred upon market entry. 
• Control Trak: Subject to Max Dollar and Max Dose edits.
Relistor® (methylnaltrexone bromide) oral tabletTreatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.Pricing information not yet available • Drug Information: Relistor contains the opioid antagonist, methylnaltrexone, to help treat constipation due to use of opioids when regular laxatives alone have not been sufficient. This tablet is dosed once daily with water on an empty stomach, and it is advised to discontinue this medication if opioids are discontinued.
• Formulary Management: Considered non-preferred upon market entry. 
• BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrakRx’s BIC Specialty Pharmacy Network. 
• Control Trak: Subject to Max Dollar and Max Dose edits.
Belviq XR® (lorcaserin hydrochloride) extended-release tabletsFor chronic weight management in adults as an adjunct to a reduced-calorie diet and increased physical activity.Pricing information not yet available• Drug Information: Belviq XR is indicated for chronic weight management in obese or overweight patients who have at least one weight-related comorbid condition. It is dosed once daily and should be discontinued if 5% weight loss is not achieved by week 12 of treatment. 
• Clinical Concierge: Belviq XR will be prior-authorized (PA) as a component  of MedTrakRx’s approval criteria for anti-obesity medications (Note: This coverage requirement applies to participating plans only). 
• Formulary Management: Considered non-preferred upon market entry. 
• Control Trak: Subject to Max Dollar and Max Dose edits.
Syndros™ (dronabinol) oral tabletTreatment of anorexia associated with weight loss in adult AIDS patients and for nausea/vomiting in adult cancer patients.Pricing information not yet available• Drug Information: Syndros is an oral solution containing the cannabinoid, dronabinol, to help treat anorexia in adult AIDS patients and nausea/vomiting in adult cancer patients who have failed or did not respond to conventional antiemetic treatment. It comes with a calibrated oral dosing syringe and is dosed twice daily, one hour before lunch and dinner with 6 to 8 ounces of water.
• Clinical Concierge: Syndros is currently being evaluated by the MedTrakRx Clinical Care Center to assess potential utilization management strategies.  
• Formulary Management: Considered non-preferred upon market entry. 
• Control Trak: Subject to Max Dollar and Max Dose edits.


The Clinical Care Center (CCC) is MedTrakRx’s comprehensive clinical solution to control costs and increase adherence for our Clients and Members. The Clinical Care Center is made up of 7 Steps to Improved Outcomes: Generics Plus, Formulary Management, Member & Client Education, RightChoice, Control Trak, Best-In-Class (BIC) SpecialtyRx, and Clinical Concierge.