FDA New Approvals
The FDA has approved Aemcolo (rifamycin), containing 194mg of rifamycin as delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for treatment of Travelers' Diarrhea caused by non-invasive strains of Escherichia coli in adults.
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The FDA has approved Bijuva (estradiol and progesterone) capsules, 1mg/100mg, a bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.
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The FDA has approved Dsuvia (sufentanil) sublingual tablets for management of severe acute pain in adults in certified, medically supervised healthcare settings. The single-strength tablet (30mcg) and single-unit, pre-filled applicator packaging are designed to mitigate the possibility of dosing errors, misuse, and diversion.
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The FDA has approved Gamifant (emapalumab-lzsg), an interferon gamma blocking antibody for the treatment of pediatric (newborn and older) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.
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The FDA has approved Hyrimoz (adalimumab-adaz) for multiple indications (rheumatoid arthritis, juvenile idiopathic arthritis in patients 4 years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis). Hyrimoz is administered by injection.
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The FDA has approved Khapzory (levoleucovorin) for injection, a folate analogue for three indications: rescue after high-dose methotrexate therapy in patients with osteosarcoma; diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination; and the treatment of patients with metastatic colorectal cancer in combination with fluorouracil. Khapzory is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission. Product supply will be available in January.
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The FDA granted accelerated approval to Lorbrena (lorlatinib) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
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The FDA has approved an oral film formulation of Sympazan (clobazam) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years and older. Sympazan is the first oral film formulation of clobazam approved by the FDA to treat seizures associated with LGS.
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The FDA has granted an approval to Udenyca (pegfilgrastim-cbqv), a pegfilgrastim (Neulasta) biosimilar, for patients with cancer receiving myelosuppressive chemotherapy.
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The FDA has approved Xofluza (baloxavir marboxil) tablets for the treatment of acute uncomplicated influenza in people aged 12 years and older who have been symptomatic for no more than 48 hours. This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in approximately 20 years. Unlike neuraminidase inhibitors, Xofluza prevents replication by inhibiting cap-dependent endonuclease activity of the viral polymerase.
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The FDA approved Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist, which is a class of medicines that improve lung function in patients with COPD. Yupelri is an inhalation solution that is administered once daily via a standard jet nebulizer.
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The Gastrointestinal Drugs Advisory Committee of the FDA voted to recommend reintroducing Zelnorm (tegaserod maleate) for the treatment of irritable bowel syndrome with constipation in women without a history of cardiovascular (CV) ischemic disease and who have no more than one risk factor for CV disease.
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FDA New Indications
A new approval was granted for Adcetris (brentuximab vedotin) in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) for adults with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the sixth FDA-approved indication for Adcetris.
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The FDA has approved Dupixent (dupilumab) as add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupixent is an interleukin-4 and interleukin-13 inhibitor. Dupixent is the only biologic approved by the FDA for patients with moderate and severe asthma with eosinophilic phenotype.
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Empliciti Plus Pomalidomide and Dexamethasone
The FDA has approved the Empliciti (elotuzumab) indication, which the combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Empliciti is also indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
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The FDA has approved the sodium-glucose cotransporter type 2 inhibitor Invokana (canagliflozin) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease. Invokana is the first oral diabetes drug indicated to reduce the risk of myocardial infarction, stroke, or death due to a cardiovascular cause.
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The FDA approved Keytruda (pembrolizumab) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC). This approval marks the first time an anti-PD-1 regimen has been approved for the first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status.
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The FDA has approved Keytruda for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
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The FDA approved Xyrem (sodium oxybate) for the treatment of cataplexy and excessive daytime sleepiness in pediatric patients (7 to 17 years old) with narcolepsy. Xyrem may only be dispensed to patients enrolled in the Xyrem REMS Program.
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Aurobindo Pharma Limited Irbesartan
Aurobindo Pharma Limited (Aurobindo) is voluntarily recalling 22 batches of irbesartan due to the presence of an impurity, N-nitrosodiethylamine. These batches were supplied to ScieGen Pharmaceuticals Inc. (ScieGen) for the manufacturing of finished irbesartan drug product. Aurobindo has notified ScieGen of the recall and is arranging for the return of all available irbesartan drug substance. Aurobindo Pharma Limited has further advised ScieGen to contact its distributors and retailers to return irbesartan drug product and finished irbesartan tablets that have been identified by Aurobindo.
Learn more about the Aurobindo irbesartan recall
Janssen Pharmaceuticals, Inc. Ortho-Novum 1/35 and 7/7/7 Tablets
Janssen Pharmaceuticals, Inc. has initiated a
voluntary recall of one lot of Ortho-Novum 1/35 (norethindrone/ethinyl
estradiol) tablets and two lots of Ortho-Novum 7/7/7 (norethindrone/ethinyl
estradiol) tablets to the pharmacy level. The patient information provided
inside affected packages of Ortho-Novum does not include the appropriate
instructions for the Veridate dispenser. The
Ortho-Novum product itself remains safe and effective for use with the appropriate dispenser instructions.
Learn more about the Janssen Pharmaceuticals, Inc. Ortho-Novum tablets recall
Kadesh, Inc. Puriton Eye Relief Drops
Kadesh, Inc. is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz (15mL) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, were manufactured without necessary production controls and conditions to assure sterility.
Learn more about the Kadesh, Inc. Puriton Eye Relief Drops recall
Liveyon, LLC ReGen Series Products
Liveyon, LLC is a distributor of stem cell products manufactured by Genetech, Inc. Liveyon has voluntarily recalled all ReGen Series products due to reported possible adverse reactions.
Learn more about the Liveyon, LLC ReGen Series products recall
Promise Pharmacy Prednisolone/Gatifloxacin 1%/0.5% Ophthalmic Solution
Promise Pharmacy is voluntarily recalling one lot of prednisolone and gatifloxacin ophthalmic solution 1%/0.5% sterile, 3mL vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution. To date, Promise Pharmacy has not received any reports of adverse events related to this recall.
Learn more about the prednisolone/gatifloxacin ophthalmic solution recall
Sandoz HCTZ/Losartan 100mg/25mg Tablets
The FDA is alerting patients and healthcare professionals to Sandoz’s voluntary recall of one lot, JB8912, of losartan potassium and HCTZ 100mg/25mg tablets. Sandoz’s product was made using an active pharmaceutical ingredient (API) that has tested positive for the impurity N-nitrosodiethylamine. The API was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd, which is on import alert.
Learn more about the Sandoz HCTZ/losartan tablets recall
ScieGen Pharmaceuticals, Inc. Irbesartan Tablets
ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of irbesartan tablets, USP 75mg, 150mg, and 300mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine, contained in the active pharmaceutical ingredient irbesartan, USP manufactured by Aurobindo Pharma Limited.
Learn more about the ScieGen Pharmaceuticals, Inc. irbesartan tablet recall
Sprayology Water-Based Homeopathic Products
The FDA is alerting consumers about a voluntary recall of all lots with expiration dates from October 2018 to July 2022 of Sprayology’s water-based homeopathic product line for human use. These products are labeled as a homeopathic and are being recalled due to microbial contamination.
Learn more about the Sprayology products recall
EpiPen Auto-injectors Carrier Tubes
The FDA is alerting patients, caregivers, and healthcare professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product. The label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube.
Learn more about EpiPen Auto-injector carrier tubes
Severe Worsening of Multiple Sclerosis After Stopping Gilenya
Gilenya (fingolimod) is one of several medicines approved to treat a form of multiple sclerosis (MS) called relapsing MS. The FDA is warning that when Gilenya is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.
Learn more about the Gilenya safety alert
Sterile Drug Products From Pharm D Solutions
The FDA is alerting healthcare professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions LLC, Houston, Texas, due to lack of sterility assurance. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Learn more about the Pharm D Solutions alert