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P T. 2013;38(4): 196-197, 216

New Drugs/Drug News/New Medical Devices April 2013


Kadcyla in Breast Cancer

Ado-trastuzumab emtansine (Kadcyla, Genentech) has been approved for patients with HER-2–positive, metastatic breast cancer who previously used the company’s trastuzumab (Herceptin) and taxanes. A boxed warning mentions a risk of liver and heart toxicities, death, and life-threatening birth defects. Pregnancy status should be verified before treatment.

Sources: FDA and GlobalData, February 22, 2013

Osphena for Painful Intercourse

Ospemifene (Osphena, Shionogi) has been approved for women experiencing pain during sexual intercourse. The pain is often a symptom of vulvar and vaginal atrophy, attributed to declining levels of estrogen hormones during menopause.

A boxed warning mentions that the drug acts like estrogen on vaginal tissues, making them thicker and less fragile and stimulating the endometrium. In post-menopausal women, however, a stimulated endometrium is not the normal condition. The boxed warning also states a risk of stroke and deep vein thrombosis.

Sources: FDA and GlobalData, February 26, 2013

Generic Approvals


Amneal Pharmaceuticals, LLC, has received the FDA’s approval for one of the first generic versions of Suboxone sublingual tablets for the maintenance treatment of patients with opioid drug dependence. Generic buprenorphine HCl/naloxone HCl dihydrate tablets are available in strengths of 2 mg/0.5 mg and 8 mg/2 mg, both in 30-count bottles. Suboxone is made by Reckitt Benckiser.

The drug was approved under a Risk Evaluation and Mitigation Strategy (REMS) program, and it is classified as a Schedule III controlled substance.

Source: Amneal, February 25, 2013

Generic Adderall XR

The FDA has approved Teva’s Abbreviated New Drug Application (ANDA) for a generic version of Shire’s Adderall XR for the treatment of attention deficit/hyperactivity disorder (ADHD). The capsules will be available in strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg. Adderall XR is a once-daily, extended-release, amphetamine product. It is a Schedule II controlled substance.

Sources: Teva, February 14, 2013;

Generic Zoledronic Acid

Agila Specialties, a subsidiary of Strides Arcolab Ltd., has received ANDA approval for zoledronic acid injection 4 mg (base)/5 mL, packaged in single-dose vials. On March 6, Sagent Pharmaceuticals, Inc., also announced the approval and launch of zoledronic acid injection 4 mg in a latex-free plastic vial.

Zoledronic acid is the generic form of Zometa (Novartis), which was scheduled to lose its patent in March 2013. It is used to treat hypercalcemia of malignancy and bone complications that may occur with chemotherapy for other cancers.

Sources:, March 6, 2013;;

Generic Doxorubicin

Doxorubicin HCL liposome injection HCl (Doxil, Janssen) has been approved via a priority review to help offset current drug shortages. The injection is used to treat leukemia and other cancers as monotherapy or in combination with other therapies. It is sold in 20-mg and 50-mg vials by Sun Pharma Global.

Source: MedPage Today, February 4, 2014

Lymphoseek Maps Lymph Nodes

Navidea’s Lymphoseek Injection (technetium Tc 99m tilmanocept) is used to locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. The physician injects the drug into the tumor area, and using a hand-held radiation detector, finds lymph nodes that have taken up the drug’s radioactivity. This diagnostic imaging agent is not a cancer-imaging drug.

Lymphoseek is the first new drug used for lymph node mapping to be approved in more than 30 years. Similar agents include sulfur colloid and isosulfan blue.

Source: FDA, March 13, 2013


Zortress to Prevent Liver Rejection

Everolimus (Zortress, Novartis) has been approved to prevent liver transplant rejection in adults. It was previously approved for preventing rejection in kidney transplant recipients. This is the first approval for a mammalian target of rapamycin (mTOR) inhibitor in liver transplantation. Everolimus is a derivative of sirolimus (rapamycin, Rapamune, Wyeth/Pfizer).

Source: MedPage Today, February 18, 2013

Stivarga for Advanced GISTs

Regorafenib (Stivarga, Bayer) is now approved to treat patients with inoperable gastrointestinal stromal tumors (GISTs) that no longer respond to imatinib (Gleevec, Novartis) or sunitinib (Sutent, Pfizer). Regorafenib was first approved in September 2012 to treat colorectal cancer.

Source: FDA, February 25, 2013

Epiduo for Acne in Children

Adapalene 0.1%/benzoyl peroxide 2.5% gel (Epiduo, Galderma) has been approved for the topical treatment of acne in children as young as 9 years of age. The drug was originally intended for patients 12 years of age and older. Treating younger patients could help to prevent future scarring.

Sources: Dermatology Times, February 19, 2013;, February 20, 2013;


Injectable Abilify

An extended-release injectable suspension of the antipsychotic drug aripiprazole (Abilify Maintena, Otsuka/Lundbeck) is now approved. This is the first dopamine D2 partial agonist given once monthly via intramuscular injection. Starting and maintenance doses are 400 mg monthly. This is the sixth FDA-approved, long-acting injectable antipsychotic medication, along with fluphenazine (Proloxin, Apothecon), haloperidol (Haldol, Janssen), risperidone (Risperdal, Janssen), paliperidone (In-vega Sustenna, Janssen), and olanzapine (Zyprexa Relprevv, Eli Lilly).

Sources: Otsuka and MedPage Today, March 2, 2013



Omontys Injection

Affymax and Takeda have voluntarily recalled all lots of peginesatide (Omontys) injection because of reports of anaphylaxis. Peginesatide is an erythropoiesis-stimulating agent used to treat anemia in adults on dialysis. It was approved in March 2012. Serious and fatal hypersensitivity reactions occurred after some patients received their first IV dose, sometimes within 30 minutes. Affymax reported 19 cases of anaphylaxis from dialysis centers in the U.S. and three deaths.

Sources: FDA and Takeda, February 23, 2013

Vistide for CMV Retinitis

One lot of cidofovir (Vistide, Gilead) (B120217A; expiration date, May 2015) has been voluntarily recalled because particulate matter was found in some vials. Cidofovir is used to treat cytomegalovirus retinitis, an opportunistic eye infection that affects AIDS patients.

Sources: FDA, February 15, 2013; MedPage Today, February 18, 2013


Arrhythmias with Zithromax

Life-threatening cardiac arrhythmias may affect patients taking azithromycin (Zithromax, Pfizer). Patients with a prolonged QT interval, bradycardia, or low serum levels of magnesium or potassium may be at risk. The warnings and precautions section of the drug’s label is being strengthened to highlight the risk of QT prolongation and torsades de pointes, a potentially lethal arrhythmia.

Sources: N Engl J Med 2012;366:1881–1890; MedPage Today, March 12, 2013

No Codeine After Tonsillectomy

Products that contain codeine should not be used in children to relieve pain after a tonsillectomy or an adenoidectomy because of a risk of serious adverse events, including death. A boxed warning is being added to the labels of all codeine products. This contraindication does not apply to other pain therapies for children.

Source: MedPage Today, February 21, 2013


Marvin M. Goldenberg, PhD, RPh, MS

Name: FerriScan R2-MRI Test for Iron Overload

Manufacturer: Inner Vision Biometrics/Resonance Health Ltd., Perth, Australia

Approval Date: January 28, 2013

Purpose: FerriScan is an analysis service that provides measurements of serum liver iron via noninvasive magnetic resonance imaging (MRI). It is a companion diagnostic device used with deferasirox (Exjade, Novartis) in patients with nontransfusion-dependent thalassemia (NTDT). Deferasirox is used to remove excess iron from patients (2 years of age and older) with chronically elevated levels of iron caused by repeated blood transfusions. FerriScan aids physicians in selecting NTDT patients for deferasirox therapy and in monitoring their response to the drug.

Approximately 4 million people in the U.S. have iron overload disease. Hemochromatosis, a genetic disorder, causes iron deposition in the liver and in other organs, resulting in iron overload. Thalassemia also results in iron overload as a result of frequent transfusions. NTDT patients are genetically predisposed to iron overload even if they are not receiving transfusions regularly.

Description: Spin-density projection MRI technology is used to capture images, which are transmitted to a FerriScan facility. A map of liver iron is produced, and the mean serum iron level is calculated. Results are available in 48 hours.

Benefit: FerriScan has the highest sensitivity and specificity in measuring liver iron of any MRI-based method. Results are as accurate as a liver biopsy.


Name: CADD-Solis Variable Infusion Profile Ambulatory Infusion System

Manufacturer: Smiths Medical, St. Paul, Minn.

Approval Date: February 6, 2013

Purpose: The pump is used to deliver analgesics, chemotherapy, hydration, antibiotics, immune globulin, and total parenteral nutrition to children and adults.

Description: Infusions can be continuous, intermittent, variable, or tapered. A smart infusion pump, medication safety software, and medication cassette reservoirs are attached to the pump. The software alerts the operator to stop the infusion if a pump setting is misprogrammed. Smart pumps recognize prescription errors and dose misinterpretations.

Benefit: Data are displayed in a simple format to reduce training time. Clinicians can download the data from a personal computer into the pump and can view infusion reports to quickly assess the treatment. Holding up to 500 protocols, the pump’s color screens differentiate each delivery mode.


Class I Cannula Recall

Bausch and Lomb’s 27G Sterile Cannula, which is used during ocular surgery, was recalled because of the possibility that viscoelastic material might leak or that the cannula might become detached from the syringe during injection. Detachment has resulted in serious patient injury. Affected lots include Amvisc 1.2% Sodium Hyaluronate (Model Nos. 59051, 59081, 59051L, and 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model Nos. 60081, 60051, 60051L, and 60081L) Ophthalmic Viscosurgical Device.

Source: FDA,, January 23, 2013