New Drug Approvals June – August 2016

Name & Dose Form Manufacturer Indication Date Approved Average Wholesale Price Projected US Sales
ER capsules
OPKP Health, Inc. Secondary Hyperparathyroidism 06/17/16 Not available at the current time $72 million annually
Oral solution
Insys Therapeutics, Inc. Anorexia Nausea/Vomiting 07/01/16 Not available at the current time $700 million annually
Pushtronex System
Amgen Inc Hyperlipidemia 07/11/16 $1,140.00
per 30 days
$185 million annually
ophthalmic solution
Shire Plc. Ophthalmic 07/11/16 $8.53
per 5ml
$6 billion
Belviq XR
ER tablet
Arena Pharmaceuticals Inc. Weight Management 07/15/16 Not available at the current time Not available at the current time
Valeant Opioid-induced
07/19/16 $120.00
per 30 days
$43.8 million
Viekira XR
AbbVie Inc. Hepatitis C Virus 07/25/16 $33,327.60
per 30 days
Not available at the current time
Sanofi-Aventis U.S. LLC Type II Diabetes 07/27/16 Not available at the current time Not available at the current time


RAYALDEE (Calcifediol)

  • OPKO Health, Inc. announced the U.S. Food and Drug Administration (FDA) approval for Rayaldee (Calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism associated with vitamin D insufficiency in patients with Stage 3 through 4 chronic kidney disease.
  • The initial dose is 30 mcg extended-release capsule administered orally once daily at bedtime. Serum calcium should be below 9.8 mg/dL before initiating treatment. After 3 months of treatment, dose can be increased to 60 mcg once daily if intact parathyroid hormone (iPTH) is above the treatment goal. Routine monitoring of laboratory parameters such as calcium, iPTH and total 25-hydroxyvitamin D while taking Rayaldee is recommended.
  • U.S. launch planned in the second half of 2016


SYNDROS (Dronabinol)

  • Syndros is the first FDA-approved dronabinol solution for oral use indicated for the treatment of loss of appetite (anorexia) associated with weight loss in patients with AIDS, and nausea and vomiting caused by cancer chemotherapy in adults who have not improved with conventional antiemetic treatments.
  • Dose recommendation varies depending on the condition being treated. Syndros is supplied in a multi-dose 30 mL glass bottle with the enclosed calibrated oral dosing syringe and the adapter for the appropriate dosing measurement.
  • U.S. launch planned in the second half of 2016


REPATHA Pushtronex System (Evolocumab)

  • Repatha is first single monthly injection. Repatha blocks a protein, PCSK9 (proprotein convertase subtilisin/ kexin type 9) which allows a removal of more LDL cholesterol from the blood. Repatha is indicated as an adjunct to diet for the treatment of patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.
  • Repatha Pushtronex System is designed to provide 420 mg of Repatha in a single dose. Previosly, Repatha was available only as 140 mg prefilled syringe and required injection with three 140 mg syringes.
  • U.S. launch planned in the month of August, 2016


XIIDRA (Lifitegrast)

  • Xiidra is a prescription eye drop approved to treat the signs and symptoms of dry eye disease. Shire Plc. is in direct competition with Allergan, the maker of Restasis.
  • Dose recommendation is one drop twice daily in each eye (approximately 12 hours apart). Xiidra (lifitegrast ophthalmic solution) 5% (50 mg/mL) is supplied in a foil pouch containing 5 low density polyethylene 0.2 mL single use containers.
  • U.S. launch planned in the third quarter of 2016


BELVIQ XR (Lorcaserin)

  • Belviq XR is approved for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol or type 2 diabetes.
  • The recommended daily dose is 20 mg as to comparison to the previous immediate-released Belviq formulation which is to be taken twice daily.
  • U.S. launch planned in Fall 2016


RELISTOR (Methylnaltrexone)

  • Valeant Pharmaceuticals received an approval for a new oral formulation (450 mg once daily) of the previously injectable-only Relistor for opioid-induced constipation (OIC) in adults.
  • Relistor targets the underlying cause of opioid-induced constipation (OIC) in adult patients without impacting opioid-mediated analgesic effects on the central nervous system and delivers constipation relief by blocking opioid binding in tissues such as the gastrointestinal tract.
  • U.S. launch planned in the third quarter of 2016


VIEKIRA XR (Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir)

  • Viekira XR is a once-daily, extended-release co-formulation of the active ingredients in Viekira PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is indicated to treat adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). Viekira XR is not for people with decompensated cirrhosis.
  • Viekira XR offers a simpler drug regimen. Patients take three tablets once a day with a meal. Treatment regimen and duration varies according to genotype. For Genotype 1a, without cirrhosis patients receive Viekira XR plus ribavirin for 12 weeks, for Genotype 1a, with compensated cirrhosis (Child-Pugh A) patients receive Viekira XR plus ribavirin for 24 weeks and for Genotype 1b, with or without compensated cirrhosis patients receive Viekira XR for 12 weeks.
  • U.S. launch planned in the month of August, 2016


ADLYXIN (Lixisenatide)

  • Adlyxin a once-daily mealtime glucogan-like peptide-1(GLP-1) receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. GLP-1 suppresses postprandial glucagon release, delay stomach emptying, and increase insulin sensitivity which significantly lower rates of hypoglycemia.
  • Initial treatment comes in a disposable pre-filled 10 micrograms single dose pen for the once daily administration for 14 days. On Day 15, patients should increase dosage to 20 micrograms once daily. Adlyxin is supplied in a disposable pre-filled pen in a single dose of 20 micrograms for subcutaneous administration.
  • Adlyxin is already marketed under the name Lyxumia in more than 40 countries, including those of the European Union, Brazil and Japan.


New Generic Drug Launches March – June 2016

Generic Brand Name Manufacturer Indication Date Launched
Fenofibrate Fenoglide Mylan Hyperlipidemia 06/23/16
Nilutamide Nilandron ANI Pharms Inc. In combination with
surgical castration
for the treatment of
metastatic prostate
Tamiflu NATCO Influenza 08/03/2016


Fenofibrate Tablets 40 mg and 120 mg, which is a generic version of Santarus’s Fenoglide. Fenofibrate is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, and apolipoprotein B to increase high-density lipoprotein in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

Nilutamide tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2). Nilutamide 300 mg once daily for 30 days is recommended, followed thereafter by 150 mg once daily. Benefit of the treatment is maximized if treatment with Nilutamide tablets begins on the same day as or on the day after surgical castration.

The U.S. Food and Drug Administration approved the first generic version of Tamiflu, Roche Group (oseltamivir phosphate) which is being prescribed for the treatment of the influenza virus in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours and for the prophylaxis of the flu in patients one year of age and older.


New Over-the-Counter Drug Approvals June – August 2016

Name & Dose Form Manufacturer Indication Date Approved
Differin Gel 0.1% Galderma Laboratories, L.P Acne 07/08/16
Omeprazole/Sodium Bicarbonate Perrigo Plc. Heartburn 07/15/16


On July 8th, 2016 the U.S. Food and Drug Administration approved Differin Gel 0.1% (adapalene), a oncedaily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older. Differin Gel 0.1% is the first in a class of drugs known as retinoids will be available OTC for the treatment of acne.

On July 15th, 2016 U.S. Food and Drug Administration has approved Perrigo company’s Abbreviated New Drug Application (ANDA) for omeprazole and sodium bicarbonate capsules, 20mg/1100mg (OTC), to be bioequivalent to the Zegerid OTC Capsules, 20 mg/1100 mg, of Bayer HealthCare, LLC. The approved indication for the treatment of the frequent heartburn.


For an impact analysis, contact your EmpiRx Health Account Executive at 201-746-6901.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

  • Complete and submit the report Online:
  • Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178

*This is provided for informational purposes only. Reference to any medication above does not mean the medication is covered by your plan.


Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivity, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

Drug News: FDA Approvals & Generic Launches March 2016 – June 2016