New FDA Drug Approvals and Recalls
Posted: Jul 15 2016
FDA Drug Approvals
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
Epclusa® (sofosbuvir and velpatasvir) oral tabletTreatment of adult patients with chronic hepatitis C virusAWP is $29,904 per month• Drug Information: Epclusa is a new combination product for the treatment of chronic hepatitis C infection. It may be used to treat all known HCV genotypes and may be used in patients with compensated cirrhosis or decompensated cirrhosis (if used in combination with ribavirin). The recommended treatment regimen is once daily with or without food for three months. 
• Formulary Management: Considered non-preferred upon market entry. 
• BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrak’s BIC Specialty Pharmacy Network. 
• Control Trak: Subject to Max Dollar and Max Dose edits.
Byvalson® (nebivolol and valsartan) oral tabletTreatment of hypertensionPricing information not yet available• Drug Information: Byvalson is a new combination hypertension therapy that includes a beta-adrenergic blocker and an angiotensin II receptor blocker to treat hypertension (nebivolol 5mg/valsartan 80mg).
• Formulary Management: Considered non-preferred upon market entry. 
• Control Trak: Subject to Max Dollar and Max Dose edits.
Gonitro® (nitroglycerin) sublingual powderFor acute relief of an attack or prophylaxis of angina pectorisPricing information not yet available• Drug Information: Gonitro is a new powder formulation of nitroglycerin. It is approved to treat acute chest pain or as prophylaxis prior to activities that may cause an acute attack of chest pain.
• Formulary Management: Considered non-preferred upon market entry
• Control Trak: Subject to Max Dollar and Max Dose edits.
Rayaldee® (calcifediol) oral capsuleTreatment for adult patients with secondary hyperparathyroidism associated with vitamin D insufficiencyPricing information not yet available• Drug Information: Rayaldee is an extended-release oral capsule used to treat adult patients with stage 3 or 4 chronic kidney disease that have secondary hyperparathyroidism and vitamin D insufficiency. It should not be given to patients in stage 5 chronic kidney disease or end-stage renal disease on dialysis.  
• Formulary Management: Considered non-preferred upon market entry. 
• Control Trak: Subject to Max Dollar and Max Dose edits.


Drug Recalls
Drug recalls are actions taken by drug manufacturer’s to remove a product from the market. Recalls may be conducted by the manufacturer on their own initiative, by request of the FDA, or mandated by the FDA. Below is a highlight of the most relevant drug recalls.

Drug Recalls
Drug NameType of RecallReason for RecallActions
Zecuity® (sumatriptan) iontophoretic transdermal systemVoluntary suspensionTeva Pharmaceuticals has temporarily suspended sales, marketing and distribution of Zecuity due to postmarketing reports of application site reactions in patients treated with Zecuity. Descriptions of the application site reactions include: severe redness, cracked skin, blistering or welts, and burns or scars where the patch was worn. • Prescribers have been advised to discontinue prescribing of Zecuity and instruct patients to discontinue use
• Health care providers and patients are encouraged to report adverse events in patients that have used Zecuity to the FDA