FDA New Approvals
The FDA has approved Hadlima (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Learn more about Hadlima
The FDA has approved Katerzia (amlodipine) oral suspension, 1mg/mL. Katerzia is indicated for the treatment of hypertension in adults and pediatric patients aged 6 years and older and of coronary artery disease in adults.
Learn more about Katerzia
The FDA has approved Recarbrio (imipenem, cilastatin, and relebactam) for injection, 1.25g, a new combination antibacterial. Recarbrio is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections, including pyelonephritis, caused by susceptible Gram-negative microorganisms. Recarbrio is also indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated intra-abdominal infections caused by susceptible Gram-negative microorganisms.
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The FDA has approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. Ruxience is a mAb biosimilar to Rituxan which works by targeting a protein called CD20, which is present on the surface of B cells. When it attaches to CD20, rituximab helps destroy the B cell.
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The FDA has approved Thiola EC (tiopronin) 100mg and 300mg enteric-coated delayed-release tablets for treatment of cystinuria. Thiola EC tablets can be taken with or without food, an advancement over the original formulation, Thiola, which has limiting food restrictions, and also provides the potential to reduce the number of tablets necessary to manage cystinuria.
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The FDA approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.
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The FDA has approved Xembify (immune globulin) 20% solution for subcutaneous injection to treat primary immunodeficiencies in patients aged 2 years and above. The approval includes but is not limited to congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
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The FDA granted accelerated approval to Xpovio (selinexor) tablets in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
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The FDA approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.
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FDA First-Time Generic Approvals
The FDA has approved multiple applications for the first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.
Learn more about Lyrica generics
FDA New Indications
The FDA has approved Botox (onabotulinumtoxinA) to ease upper limb spasticity in children and adolescents aged 2 to 17 years. Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke.
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The FDA approved Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
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The FDA has approved an expansion of the use of the platelet booster Doptelet (avatrombopag) to include adults with thrombocytopenia and chronic immune thrombocytopenia that have not responded adequately to previous treatment.
Learn more about Doptelet
The FDA approved Dupixent (dupilumab) to treat adults with nasal polyps accompanied by chronic rhinosinusitis. Dupixent is given by subcutaneous injection. This is the first treatment approved for inadequately controlled chronic rhinosinusitis with nasal polyps.
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The FDA has approved an sNDA for Emflaza (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy who are aged between 2 and 5 years. Emflaza was first approved by the FDA in February 2017 for the treatment of Duchenne in patients aged 5 years or more.
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The FDA has approved Keytruda (pembrolizumab) as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This accelerated approval is 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. This marks the first indication for Keytruda in SCLC.
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The FDA approved Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). Keytruda was approved for use in combination with platinum and fluorouracil for all patients and as a single agent for patients whose tumors express PD L1 (combined positive score ≥1) as determined by an FDA approved test. The FDA also expanded the intended use for the PD-L1 IHC 22C3 pharmDx kit to include use as a companion diagnostic device for selecting patients with HNSCC for treatment with pembrolizumab as a single agent
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The FDA approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord.
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The FDA expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of pediatric patients aged 6 years and older with cystic fibrosis who have certain genetic mutations. Last year, the FDA approved Symdeko to treat patients aged 12 and older who had the same specific genetic mutations.
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FDA New Dosing
The FDA has approved Baqsimi (glucagon) nasal powder 3mg for the treatment of severe hypoglycemia in people with diabetes ages four years and above. Baqsimi is the first and only nasally administered glucagon, and it was designed with severe hypoglycemia rescue in mind. It is compact, portable and ready to use (no reconstitution required) in a single, fixed, 3mg dose.
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The FDA has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a prefilled safety syringe, which patients or caregivers can administer at home once every 4 weeks. Nucala is the first anti-interleukin-5 biologic to be licensed in the US for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector. It is currently indicated for eosinophilic granulomatosis with polyangiitis and as an add-on maintenance therapy in patients with severe asthma with eosinophilic phenotype.
Learn more about Nucala
Altaire Pharmaceuticals Ophthalmic Products
Altaire Pharmaceuticals is voluntarily recalling multiple prescription
ophthalmic ointments, within expiry, including neomycin and polymyxin B and
bacitracin zinc, NEO-POLY DEX (neomycin and polymyxin B and dexamethasone),
NEO-POLYCIN HC (neomycin and polymyxin B and bacitracin zinc and hydrocortisone
acetate), POLYCIN (polymyxin B and bacitracin zinc), bacitracin ophthalmic
ointment, sulfacetamide sodium, and Puralube (OTC). As a precautionary measure,
Altaire is initiating the recall due to management concerns regarding the
sufficiency of quality assurance controls over critical systems in the
manufacturing facility. This recall is being carried out to the retail level
and is only for certain lots. These products are being voluntarily recalled from
Learn more about the Altaire Pharmaceuticals ophthalmic products recall
Altaire Pharmaceuticals Ophthalmic Products at CVS
Altaire Pharmaceuticals announced that it is voluntarily recalling specific OTC drug products and lots, within expiry, sold at CVS Health during particular time periods. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of quality assurance controls over critical systems in the manufacturing facility.
Learn more about the Altaire Pharmaceuticals ophthalmic products recall at CVS
Bayer Kogenate FS Antihemophilic Factor
Bayer is voluntarily recalling two lots of
Kogenate FS antihemophilic factor (recombinant) 2000 IU vials to the patient
level. Certain vials from these two lots that were labeled as Kogenate FS
actually contain the FVIII hemophilia A treatment, Jivi antihemophilic factor
(recombinant) PEGylated-aucl 3000 IU. The US is the only country where affected
products were distributed. The affected lots were distributed from February 5,
2019 to July 15, 2019 from Bayer’s distribution sites in Berkeley, CA and
Learn more about the Bayer Kogenate FS antihemophilic factor recall
DaVinci Laboratories Omega-3 1000
Out of an abundance of caution, DaVinci Laboratories is voluntarily recalling 256 bottles of Omega-3 1000 that may be labeled as Dim Plex. A small number of bottles may contain undeclared fish (anchovy & sardines) allergen. People who have an allergy or severe sensitivity to fish run the risk of serious or life-threatening allergic reaction if they consume these products. Product is contained in a white plastic bottle marked with lot #35532200 and 0522 expiration on the side of the label. The UPC code on the Dim Plex label is 026664273161.
Learn more about the DaVinci Laboratories Omega-3 1000 recall
Fresenius Kabi Fluorouracil Injection
Fresenius Kabi is voluntarily recalling two lots of fluorouracil injection,
USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, to the user level, due to
the potential for glass particulate. The affected lots, 6120341 and 6120420, were
distributed between December 6, 2018 and February 20, 2019.
Learn more about the Fresenius Kabi fluorouracil injection recall
Herbal Doctor Remedies Drug Products
Herbal Doctor Remedies is voluntarily recalling all drug products within
expiry to the consumer level. These products have been marketed without FDA
approval and were manufactured outside of the controls required by current Good
Manufacturing Practices. These products could potentially result in risk to
consumers as they are marketed with intended uses not amendable to self-diagnosis.
In addition, lack of controls in the manufacture of the products do not provide
assurances of finished product quality. To date, Herbal Doctor Remedies has not
received any reports of adverse events related to this recall.
Learn more about the Herbal Doctor Remedies drug products recall
Infusion Options Sterile Products
Infusion Options is voluntarily recalling all lots of all sterile products
within expiry to the hospital level. These products are being recalled due to a
lack of assurance of sterility.
Learn more about the Infusion Options sterile products recall
Jubilant Cadista Pharmaceuticals Drospirenone and Ethinyl Estradiol Tablets
Jubilant Cadista Pharmaceuticals Inc. is
voluntarily recalling one lot of drospirenone and ethinyl estradiol tablets,
USP, 3mg/ 0.02mg, 28x3 blister pack/carton to the consumer level. The affected
product is being recalled due to out-of-specification dissolution results at
the 3-month stability time point.
Learn more about the Cadista Pharmaceuticals drospirenone and ethinyl estradiol tablets recall
Macleods Pharmaceuticals Losartan Potassium and Losartan Potassium/HCTZ
Macleods Pharmaceuticals has initiated a voluntary recall to the patient level of 32 lots of losartan potassium USP tablets (2 lots of 50mg strength) and losartan potassium/HCTZ combination tablets (12 lots of 50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 lots of 100mg/25mg strength) due to the detection of trace amounts of an unexpected impurity, N-nitroso-N-methyl-4-aminobutyric acid.
Learn more about the Macleods Pharmaceuticals losartan potassium and losartan potassium/HCTZ recall
PharMEDium Hydromorphone HCl in Sodium Chloride
PharMEDium is voluntarily recalling 45 lots of 0.5mg/mL hydromorphone HCl
in 0.9% sodium chloride 1mL in 3mL BD syringe to the user level. The product is
being recalled because PharMEDium’s electronic customer ordering system stated
it is sulfite-free, but the product contains sulfite. Serious adverse reactions
could occur in patients with a sulfite allergy who are exposed to hydromorphone
Learn more about the PharMEDium hydromorphone HCl in sodium chloride recall
Premier Pharmacy Labs Sterile Products
Premier Pharmacy Labs is voluntarily recalling all unexpired products,
intended to be sterile, due to a lack of sterility assurance. There were concerns
presented during the latest FDA inspection, including insufficient
environmental controls, potential cross-contamination, and lack of product-specific
process validations. The potentially affected lots were distributed between January
9, 2019 and May 2, 2019. The nationwide recall includes lots of sterile drug
products to the consumer/user level.
Learn more about the Premier Pharmacy Labs sterile products recall
RXQ Compounding Sterile Products
RXQ Compounding is voluntarily
recalling all sterile human and animal products within expiry, to the user
level, due to lack of sterility process assurance associated with production.
In addition, RXQ is voluntarily ceasing all sterile production at its current
location as it transitions into its new outsourcing facility.
Learn more about the RXQ Compounding sterile products recall
Kratom NC’s Products
The FDA is warning consumers not to use products marketed by Kratom NC due to microbial contamination. FDA laboratory analysis of Kratom NC’s raw materials and finished products identified various microorganisms, including Klebsiella pneumoniae, Enterobacter spp. and Escherichia sp. The FDA contacted Kratom NC to recommend recall all of its products currently on the market. However, the company has not yet taken any action to recall these potentially dangerous products.
Learn more about the FDA alerting consumers not to use Kratom NC’s products
Letco Medical L-glutathione
The FDA warned compounders in February 2019 not to use Letco Medical’s repackaged glutathione L-reduced powder (L-glutathione) to compound sterile injectable drugs. The FDA received a report concerning seven patients who received an injectable drug compounded with L-glutathione and experienced adverse events due to potentially high levels of endotoxins. The L-glutathione powder the pharmacies received was labeled with “Caution: Dietary Supplement” and should not have been used to compound sterile injectable drugs.
Learn more about concerns using Letco Medical L-glutathione to compound sterile products
Pacifico National Sterile Products
The FDA is warning patients and healthcare professionals not to use products intended to be sterile produced by Pacifico National, doing business as AmEx Pharmacy, due to a lack of sterility assurance.
Learn more about the FDA warning about sterile products from Pacifico National
Truvada REMS Updates
The FDA announced the elimination of the REMS for Truvada and its four approved generics. With the removal of the REMS for emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP), drug manufacturers are no longer required to provide educational materials; however, the approved labeling and medication guide explaining the risks and benefits of the product will continue to convey the important safety information and be widely available. Prescribers should continue to follow the labeled directions for the initiation and proper use of Truvada for the PrEP indication to minimize the risk of developing resistant HIV-1 variants when HIV-1 infection is present.
Learn more about Truvada REMS updates
Xeljanz/Xeljanz XR: Boxed Warning
The FDA has approved new warnings about an increased risk of blood clots and of death with the 10mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines.
Learn more about the FDA boxed warning for Xeljanz/Xeljanz XR