FDA New Approvals
The FDA approved Annovera (segesterone acetate and ethinyl estradiol) vaginal system, which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year. Annovera is a reusable ring, non-biodegradable, flexible vaginal system that is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a withdrawal bleed. This schedule is repeated every four weeks for one year (thirteen 28-day menstrual cycles).
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The FDA has approved Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older. This is the first time in more than eighteen years that the FDA has approved a new drug for the prevention of malaria. Arakoda is supplied in 100mg tablets for oral use only. After an initial loading dose prior to traveling, Arakoda is intended to be taken once a week, which could offer convenience to the traveler.
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The FDA has approved Azedra (iobenguane I 131), a radioactive injection for intravenous use for the treatment of adults and adolescents aged 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that are unresectable, have spread beyond the original tumor site, and require systemic anticancer therapy. This is the first FDA-approved drug for this use.
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The FDA has approved Cequa (cyclosporine ophthalmic solution) 0.09%; it is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). Cequa provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA.
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The FDA has approved Diacomit (stiripentol) for seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. Diacomit is not indicated as monotherapy in Dravet syndrome. The approved recommended dosage of Diacomit capsules or powder for oral suspension is 50mg/kg/day by mouth in 2 or 3 divided doses.
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The FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation determined to be responsive (“amenable”) to treatment with Galafold based on laboratory data. Fabry disease is a rare and serious genetic disease that results from buildup of a type of fat called globotriaosylceramide in blood vessels, the kidneys, the heart, the nerves, and other organs.
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The FDA has approved Jornay PM (methylphenidate), a formulation that is taken in the evening instead of first thing in the morning to provide early-morning control of symptoms of ADHD. Jornay PM is for children aged 6 years and older. It should be taken at 8:00 PM, although timing of administration may be adjusted to between 6:30 PM and 9:30 PM to optimize the tolerability and the efficacy the next morning and throughout the day.
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The FDA approved Lenvima (lenvatinib) capsules for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The dose for Lenvima for patients with unresectable HCC is based on the patient’s weight (12mg for patients weighing 60kg or more, 8mg for patients weighing less than 60kg).
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The FDA approved Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Lusutrombopag interacts with the transmembrane domain of human TPO receptors expressed on megakaryocytes to induce the proliferation and differentiation of megakaryocytic progenitor cells from hematopoietic stem cells and megakaryocyte maturation.
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The FDA has approved Omegaven (fish oil triglycerides) injection emulsion for provision of calories and fatty acids for pediatric patients with parenteral nutrition-associated cholestasis. Cholestasis is a condition in which bile is not released from the liver. It may occur when patients are receiving parenteral nutrition. Omegaven is injected intravenously by a healthcare provider and is administered daily over 8 to 24 hours.
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The FDA approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart, and other organs. It is also the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
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The FDA has approved Perseris (risperidone), the first once-monthly subcutaneous injection of risperidone, for the treatment of schizophrenia in adults. Perseris uses an extended-release delivery system to form a subcutaneous depot that provides sustained levels of risperidone over 1 month. Clinically relevant levels of the drug are reached after the first injection without use of a loading dose or any supplemental oral dose of risperidone.
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The FDA has approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.
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FDA First-Time Generic Approvals
EpiPen and EpiPen Jr
The FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3mg and 0.15mg strengths.
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FDA New Dosing
Atropine Sulfate Injection
Fresenius Kabi announced the immediate availability in the US of atropine sulfate injection, USP in an 8mg per 20mL presentation. It is the first and currently only atropine sulfate 8mg per 20mL multiple-dose vial approved by the FDA. Atropine is a muscarinic antagonist indicated for the temporary blockade of severe or life-threatening muscarinic effects.
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Remodulin Implantable System
Remodulin was originally approved by the FDA to treat PAH by continuous subcutaneous and intravenous routes of administration in 2002 and 2004, respectively, using external pumps. Remodulin (treprostinil) Injection in the Implantable System for Remodulin (ISR) provides patients a new option for delivery of intravenous Remodulin, where the entire delivery system is implanted into the body and will be refilled by healthcare professionals at intervals of up to 16 weeks depending on the patient’s dose, using a syringe needle through the patient’s skin.
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FDA New Indications
The FDA has approved Granix (tbo-filgrastim) injection for a new vial presentation and indication in pediatric patients 1 month and older. Granix is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. The new vial presentation of the product will be available for use in 300mcg/1mL and 480mcg/1.6mL single-dose vials. The prefilled syringe presentations will continue to be available as well.
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The FDA expanded the indication for Kisqali (ribociclib) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. The FDA also approved Kisqali in combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.
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The FDA has approved an expanded label for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
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The FDA has further expanded the use of the
cystic fibrosis (CF) drug Orkambi (lumacaftor and ivacaftor) for children as
young as age 2 who have two copies of the F508del
mutation in the CF transmembrane conductance regulator gene, the most common
cause of the disease.
Learn more about Orkambi
AuroMedics Pharma Piperacillin and Tazobactam for Injection
AuroMedics Pharma LLC is voluntarily recalling two lots of piperacillin and tazobactam for injection, USP 3.375g (piperacillin sodium equivalent to 3g of piperacillin USP and tazobactam sodium equivalent to 0.375g of tazobactam USP. Each vial contains 7.05 mEq (162mg) of sodium in a single-dose vial. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was found to contain silicone material.
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Camber Pharmaceuticals, Inc. Valsartan Tablets
Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of valsartan tablets, USP, 40mg, 80mg, 160mg, and 320mg to the hospital, retail and consumer level. This recall of multiple batches of valsartan tablets was prompted due to the detection of trace amounts of NDMA, a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).
Learn more about the Camber Pharmaceuticals, Inc. valsartan tablets recall
King Bio Pediatric Products
King Bio is voluntarily recalling a number of pediatric products to the consumer level. A small percentage of its products produced between August 2017 and April 2018 have tested positive for microbial contamination. Out of an abundance of caution, King Bio has issued the recall. Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. The products were distributed Nationwide to distributors and retail stores August 2017 through July 2018.
Learn more about the King Bio pediatric product recall
Major Pharmaceuticals Valsartan Products
The distribution firm Major Pharmaceuticals is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals, which may contain the carcinogen NDMA.
Learn more about the Major Pharmaceuticals valsartan products recall
Prinston Pharmaceutical Inc. Valsartan and Valsartan/Hydrochlorothiazide Tablets
Prinston Pharmaceutical Inc., dba Solco Healthcare LLC, is voluntarily recalling all lots of valsartan tablets, 40mg, 80mg, 160mg, and 320mg; and valsartan-hydrochlorothiazide tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the consumer level. This product recall is due to the detection of a trace amount of an unexpected impurity, NDMA, in an active pharmaceutical ingredient by the manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd. in the manufacture of the subject product lots.
Learn more about the Prinston Pharmaceutical Inc. valsartan and valsartan-hydrochlorothiazide tablets recall
Product Quest Manufacturing CVS Health 12 Hour Sinus Relief Nasal Mist
Product Quest Manufacturing is voluntarily
recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear,
colorless liquid. The product was found to have had microbiological
contamination identified as Pseudomonas aeruginosa.
Learn more about the Product Quest Manufacturing CVS Health 12 Hour Sinus Relief Nasal Mist recall
Ranier’s Rx Laboratory Sterile Compounded Products
Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by the FDA.
Learn more about the Ranier’s Rx Laboratory sterile compounded products recall
Sichuan Friendly Pharmaceutical Co. Porcine Thyroid API
The FDA is alerting API repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. The FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism (underactive thyroid).
Learn more about the Sichuan Friendly Pharmaceutical Co. porcine thyroid API recall
Teva Pharmaceuticals USA Valsartan and Valsartan-Hydrochlorothiazide Products
Teva Pharmaceuticals USA is voluntary recalling to the consumer/user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the US due to the detection of trace amounts of an unexpected impurity found in an API manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is NDMA.
Learn more about the Teva Pharmaceuticals USA valsartan and valsartan-hydrochlorothiazide products recall
Torrent Pharmaceuticals Valsartan/Amlodipine and Valsartan/Amlodipine/Hydrochlorothiazide
Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of valsartan/amlodipine/hydrochlorothiazide, valsartan/amlodipine, and valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an API manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is NDMA.
Learn more about the Torrent Pharmaceuticals recall
Westminster Pharmaceuticals Thyroid
Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Thyroid (levothyroxine and liothyronine) 15mg, 30mg, 60mg, 90mg, and 120mg tablets. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with cGMP.
Learn more about the Westminster Pharmaceuticals Thyroid tablets recall
World Organix Products
World Organix LLC is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the FDA and found to be contaminated with high microbial loads.
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Zakah Life Kratom Products
Zakah Life, LLC of Ankeny, Iowa, is recalling
the following kratom products (Super Green Maeng Da Premium Kratom powder,
Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium
Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with
expiration dates prior to 01/01/2023 because they have the potential of being
contaminated with Salmonella.
Learn more about the Zakah Life kratom products recall
Azithromycin and Increased Risk of Cancer Relapse in Patients with Lung Conditions
The FDA is warning that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.
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Keytruda and Tecentriq Efficacy Issue
The FDA has alerted healthcare professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1. The FDA has updated the prescribing information for Keytruda and Tecentriq to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two different companion diagnostic tests were approved by the FDA, one for use with Keytruda and one for use with Tecentriq.
Learn more about Keytruda and Tecentriq