Generic Sustiva Launched
On January 2, 2018, Rising Pharmaceuticals announced the launch of the Bristol-Myers’ Squibb’s Sustiva (efavirenz) capsules. The drug, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is used along with other antiretroviral drugs to treat patients who have HIV-1 in adults and pediatric patients (as young as 3 months old).
Lynparza Receives Approval for New Indication
On January 12, 2018, the Food and Drug Administration (FDA) approved Lynparza (olaparib) tablets for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. Lynparza was initially approved by the FDA to treat patients with BRCA-mutated, advanced ovarian cancer who have received three or more treatments of chemotherapy, and for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors have completely or partially responded to chemotherapy. It is available as 100mg and 150mg strength tablets. Read more
Prescription Opioid Cough/Cold Meds Only Indicated for Adults
According to a new safety communication, the Food and Drug Administration (FDA) is requiring that changes be made to the labeling of prescription cough and cold medicines containing codeine and hydrocodone. Parents are advised that colds rarely need drug treatment and that opioid-containing products are not appropriate for children’s’ coughs and colds. Prescribers are being reminded that alternative drugs – both prescription and non-prescription – are available, if needed. Caregivers and doctors should work together to determine the best treatment for each child.
Expanded Indication for Fluarix Quadrivalent
The Food and Drug Administration (FDA) has expanded the indication of Fluarix Quadrivalent to include use in patients aged ≥6 months for active immunization against influenza A subtype viruses and type B viruses. Fluarix Quadrivalent was initially approved in 2012 for use in patients aged ≥3 years. It contains four strains of inactivated, standardized influenza virus that produces antibodies after vaccination. Dosing is the same (0.5mL) for all age groups. For children up to eight years old who have not had flu vaccinations before, two doses are recommended to be given one month or more apart in the first year. Most previously vaccinated children need only one shot per flu season, but particularly vulnerable children, such as those with serious chronic health conditions, may be better protected with two. Read more
Trulance Gains New Indication
On January 25, 2018, the Food and Drug Administration (FDA) approved Trulance (plecanatide) tablets for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). rulance, a guanylate cyclase-C agonist, is already indicated to treat adults with chronic idiopathic constipation (CIC). Apart from a single amino acid substitution, Trulance is structurally identical to human uroguanylin and is thought to replicate the pH-sensitive activity of uroguanylin. Trulance is available as 3mg tablets in 30-count bottle and a 30-count calendar blister pack. Recommended dosing is one tablet (3mg) once daily. Trulance should not be used by patients younger than 18 years old because it could cause serious, even fatal, dehydration.
Cosentyx Label Updated
On February 8, 2018, the Food and Drug Administration (FDA) approved updated labeling to include the use of Cosentyx to treat moderate to severe psoriasis of the scalp. Cosentyx, an interleukin-17A (IL-17A) antagonist, is approved to treat moderate to severe plaque psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Recommended dosing is one subcutaneous (SC) injection per week for five weeks and then once every four weeks.
Expanded Use of Feraheme
On February 5, 2018, the FDA approved an additional use for Feraheme (ferumoxytol injection) to include all eligible adults with iron deficiency anemia (IDA) who have intolerance to oral iron or have had unsatisfactory response to oral iron. Feraheme, a hematinic, was initially approved by the FDA in 2009 to treat IDA in adults with chronic kidney disease (CKD). Administered as 510mg intravenous (IV) infusions, two doses of Feraheme are given between three days and eight days apart. An observation period of a least one-half hour is suggested following each infusion.
Zytiga Receives Additional Approval
On February 7, 2018, the FDA approved Zytiga in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer(CSPC). Zytiga, a CYP17 inhibitor, is already indicated to treat patients with metastatic castration-resistant prostate cancer (CRPC) in combination with prednisone. For both indications, the recommended dose of Zytiga is 1,000mg once daily on an empty stomach with prednisone 5mg twice daily.
New Dosing Form Approved for Makena
On February 15, 2018, the Food and Drug Administration (FDA) approved the Makena (hydroxyprogesterone caproate) subcutaneous (SC) auto-injector as a ready-to-use treatment to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. Makena is also available as 250mg/mL strength vials for deep intramuscular (IM) injection. The SC auto-injector is anticipated to launch in the second half of March and priced equally with the IM version. The IM formulation will continue to be available in single- and multi-dose vials. Both IM and SC injections must be given by a healthcare provider. They begin between weeks 16 and 21 of the pregnancy, and then continue until week 37 or the birth of the child. Recommended dosing for the SC form is one 275mg dose injected once a week into the back of the upper arm.
New Strength of Glatopa Available
On February 13, 2018, Sandoz announced the launch of Glatopa (glatiramer acetate injection) 40mg/mL, a fully-substitutable AP-rated generic version of Copaxone, for the treatment of patients with relapsing forms of multiple sclerosis (MS). In addition to the 40mg/mL strength, Glatopa is also available as a 20mg/mL injection, allowing for a complete range of dosing options for MS patients. Sandoz offers patients a proprietary injection aid, Glatopaject®, which fits both the 40mg/mL syringes and those containing 20mg/mL. The two strengths are not interchangeable, however. Glatopa 20mg/mL was FDA approved in June 2015; Mylan introduced a generic to both strengths of Copaxone in October 2017; and other generics are being developed for the U.S. market.
On February 22, 2108, the FDA issued a safety communication stating that the use of the antibiotic clarithromycin may potentially increase the risk for heart problems or death in patients with heart disease. As such, the Agency is asking healthcare professionals to use caution before prescribing the antibiotic to this patient population. Clarithromycin, a macrolide antibiotic, is used to treat various infections including mild to moderate susceptible pharyngitis/tonsillitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, acute maxillary sinusitis, acute otitis media, uncomplicated skin and skin structure infections, and Mycobaterium avium complex infection. The recommendation was made after evaluating information from a 10-year-long follow-up study. The FDA determined that the risk of heart problems and heart-disease-related deaths — sometimes delayed by many years — is increased after taking clarithromycin. Even some patients who took only one brief course of clarithromycin were affected. As a result, a new warning has been added to the prescribing information for clarithromycin to alert prescribers of this increased risk in patients with heart disease. Clinicians are being advised to weigh the benefits and risks of clarithromycin use and consider alternatives for these patients, even if clarithromycin is being used for a short period of time.
New Drug for Short Term Treatment of Acute Pain
On February 23, 2018, the Food and Drug Administration (FDA) approved Apadaz (benzhydrocodone and acetaminophen; for the short-term (≤14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Apadaz is an immediate-release combination of benzhydrocodone, a prodrug of hydrocodone, and acetaminophen (APAP). Benzhydrocodone is chemically inert, however, once ingested, enzymes in the gastrointestinal tract cleave the ligand from the prodrug and release hydrocodone, producing a therapeutic effect. The recommended dose is one or two tablets every four to six hours as needed. No more than 12 tablets should be taken in any 24-hour period and treatment should last no longer than two weeks. Apadaz will be a schedule C-II controlled substance.
New Approval for Pain Associated with Postherpetic Neuralgia
On February 28, 2018, the FDA has approved ZTlido (lidocaine topical system) 1.8% for the relief of pain associated with post-herpetic neuralgia(PHN). ZTlido uses a different type of patch design and is bioequivalent to currently available lidocaine patches, such as Lidoderm® (lidocaine) Patch 5%. It has a unique adhesive, as well, which provides more consistent skin contact.
Latuda Receives Pediatric Indication
On March 7, 2018, the Food and Drug Administration (FDA) approved Latuda (lurasidone) to treat pediatric patients aged 10-17 years with major depressive episodes associated with bipolar I disorder. Recommended pediatric dosing ranges from 20mg to 80mg per day in one dose. It also is indicated to treat adults with bipolar depression as well as patients 13 years old and older who have schizophrenia. Latuda does carry a boxed warning that all antidepressant drugs increase the risk of suicide and suicidal behaviors among children, teens, and young adults.
Zinbrynta Being Pulled From the Market
On March 2, 2018, Biogen and Abbvie announced that Zinbryta (daclizumab), a treatment for relapsing multiple sclerosis (MS), will be withdrawn from the market worldwide. Zinbryta, an interleukin-2 (IL-2) receptor blocking antibody, was approved in May 2016 to treat adults with relapsing forms of MS. Because of its safety profile, the use of Zinbryta was generally reserved for patients who had had an inadequate response to two or more drugs indicated for the treatment of MS. The decision to discontinue marketing was made following reports of brain inflammation, known as inflammatory encephalitis and meningoencephalitis, in patients taking the drug. Although a removal timeline has not been established, Biogen and AbbVie will work collaboratively with FDA and healthcare providers in the management of Zinbryta patients.
New Treatment for Swimmer’s Ear
On March 2, 2018, the FDA approved Otiprio (ciprofloxacin otic suspension) 6% for for the treatment of acute otitis externa (AOE) in patients ≥6 months old due to Pseudomonas aeruginosa and Staphylococcus aureus. Otiprio is a sterile, preservative-free, otic suspension that is administered as a single-dose to the external ear canal of each affected ear by a healthcare professional. Otiprio is also indicated for intratympanic administration in pediatric patients (≥6 months) with bilateral otitis media with effusion undergoing tympanostomy tube placement. Unlike most ear drops, Otiprio thickens when warm, making it cling to the ear canal for optimal contact.
Toujeo Max Solostar Receives Approval
On March 27, 2018, the Food and Drug Administration (FDA) approved Toujeo (insulin glargine 300 Units/mL) Max SoloStar, a long-acting insulin pen that holds 900 Units of Toujeo and provides up to 160 Units/mL per injection. Toujeo, a long-acting human insulin analog, is indicated to improve glycemic control in adults with diabetes mellitus. As the Toujeo Max SoloStar pen has a higher capacity and can deliver a maximum dose of up to 160 Units/mL, it can potentially reduce the number of pens used as well as the number of injections needed to deliver the required dose of insulin glargine to patients with diabetes. Sanofi plans to introduce the larger pens in the third quarter of 2018 at the same cost as the original, smaller one.
Updated Labeling for Tresiba
On March 26, 2018, the FDA approved an update to the prescribing information for Tresiba (insulin degludec). The labeling will now state that Tresiba does not increase the chance of adverse cardiovascular effects when compared to insulin glargine and that rates of severe hypoglycemia decreased by about 40% when compared to insulin glargine.