FDA New Approvals
The FDA approved Consensi (amlodipine besylate and celecoxib) for individuals with osteoarthritis pain and hypertension. Consensi is a patent-protected combination of celecoxib, a non-steroidal anti-inflammatory drug, and amlodipine besylate, an antihypertensive calcium channel blocker. Consensi was approved for once daily use in three dosage forms, corresponding to the current approved dosages of amlodipine (2.5, 5, and 10mg) for hypertension and a 200mg dose of celecoxib for the treatment of osteoarthritis pain.
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The FDA has approved Fulphila (pegfilgrastim-imdb), the first biosimilar to Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor used to reduce infection risk in patients with cancer. Fulphila is approved for use to decrease the risk for infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
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The FDA has approved Imvexxy (estradiol) vaginal inserts for women with moderate to severe dyspareunia resulting from menopause. The vaginal inserts, which will be available as 4μg and 10μg softgel capsules in July, are the only product in their therapeutic class to offer those doses, and the 4μg dose is now the lowest approved dose of vaginal estradiol on the market.
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The FDA has approved moxidectin 8mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. Moxidectin is a macrocyclic lactone anthelmintic medicine that selectively binds to the parasite's glutamate-gated chloride ion channels. These channels are vital to the function of invertebrate nerve and muscle cells.
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The FDA has approved the 2mg dose of Olumiant (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. Use of Olumiant in combination with other Janus kinase inhibitors or biologic disease-modifying antirheumatic drug, or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. Olumiant may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drug. Olumiant is approved with a Boxed Warning for the risk of serious infections, malignancies and thrombosis.
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The FDA approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down phenylalanine (Phe), an amino acid present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages. Palynziq is a novel enzyme therapy for adult PKU patients who have uncontrolled blood Phe concentrations on current treatment.
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The FDA has approved Yonsa (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer.
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FDA New Dose Strengths
The FDA has approved a 3500 IU vial size for Idelvion (coagulation factor IX (recombinant), albumin fusion protein), a novel, long-acting recombinant albumin fusion protein for treating hemophilia B. For some patients requiring high doses of Idelvion, the 3500 IU vial size will reduce the reconstitution time needed to prepare multiple vials for a similar dose. Idelvion is the first and only FDA-approved factor IX therapy that delivers zero median annualized spontaneous bleeding rate and is approved for up to 14-day dosing in appropriate patients.
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FDA New Indications
The FDA has granted approval for a new indication for Alimta (pemetrexed for injection) in combination with carboplatin and Keytruda (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, irrespective of PD-L1 expression status. Under the FDA's accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival. 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 Avastin (bevacizumab) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection.
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The FDA has approved extending the label for Cimzia (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque psoriasis. Cimzia is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval makes Cimzia the first Fc-free, PEGylated anti-TNF treatment option for this indication. The approval also follows a recent FDA label update for Cimzia in pregnancy and breastfeeding that provides essential information to healthcare professionals and women.
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The FDA granted accelerated approval to Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after two or more prior lines of therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This is the second indication for Keytruda for the treatment of a hematologic malignancy.
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The FDA has approved Keytruda for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This approval marks the first indication for Keytruda in a gynecologic cancer.
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The FDA approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA.
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The FDA approved Prolia (denosumab) for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. This is the fifth indication for Prolia for men and women at high risk of fracture receiving systemic glucocorticoid therapy.
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The FDA has approved Rituxan (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV). Rituxan is the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years.
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The FDA has approved, under priority review, Venclexta (venetoclax tablets) in combination with Rituxan (rituximab) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Venclexta plus rituximab is the first oral-based, chemotherapy-free combination in CLL that allows patients an option for fixed treatment duration. The FDA has also approved expansion of the indication of Venclexta as monotherapy for CLL or SLL patients, with or without 17p deletion, who have received one prior therapy.
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The FDA expanded approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis. Xeljanz is the first oral medication approved for chronic use in this indication. Other FDA-approved treatments for the chronic treatment of moderately to severely active ulcerative colitis must be administered through an intravenous infusion or subcutaneous injection.
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Allergan plc Taytulla
Allergan plc voluntarily recalled one lot (Lot# 5620706, Expiry May-2019) of Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of Taytulla. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
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Apotex Corp Fluticasone Propionate Nasal Spray
Apotex Corp. is voluntarily recalling one lot of fluticasone propionate nasal spray, USP, 50mcg per spray, 120 metered sprays, to the consumer level. The fluticasone propionate nasal spray USP 50mcg per spray 120 metered sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.
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Hospira, Inc. Naloxone Hydrochloride Injection
Hospira, Inc., a Pfizer company, is voluntarily
recalling lots72680LL and 76510LL of naloxone
hydrochloride injection, USP, 0.4mg/mL, 1mL in 2.5mL, Carpuject single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the
potential presence of embedded and loose particulate matter on the syringe
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Shadow Holdings X-Jow and Acne Shave Products
Shadow Holdings is voluntarily recalling all lots, within expiry, of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria.
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Benzocaine Over-the-counter Oral Products
The FDA is warning that over-the-counter oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label. These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine, a local anesthetic, can cause a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, can be life-threatening and result in death.
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Dolutegravir and the Potential Risk of Neural Tube Birth Defects
The FDA is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus. Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.
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Guardian Pharmacy Services Compounded Triamcinolone-Moxifloxacin
At least 43 patients reported adverse events after receiving
eye injections of
Guardian Pharmacy Services compounded
triamcinolone-moxifloxacin product during cataract surgery. The patients
reportedly experienced various symptoms, including vision impairment, poor
night vision, loss of color perception, and significant reductions in
best-corrected visual acuity and visual fields. The FDA identified
multiple substances in Guardian’s product, including poloxamer 407 and
poloxamer 407 degradants.
Learn more about Guardian Pharmacy Services compounded triamcinolone-moxifloxacin
Keytruda and Tecentriq Monotherapy Efficacy Issue
The FDA is alerting healthcare professionals, oncology clinical investigators, and the public about decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of PD-L1.
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