FDA New Approvals
KemPharm, Inc. announced that the FDA approved its new drug application for Apadaz for the short-term 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 KemPharm’s prodrug, benzhydrocodone, and acetaminophen.
Learn more about Apadaz
The FDA has approved Osmolex ER (amantadine) extended-release tablets for the treatment of Parkinson's disease and drug-induced extrapyramidal symptoms in adults. Osmolex ER tablets are a proprietary formulation containing a combination of immediate-release and extended-release amantadine. Taken once daily in the morning, the Osmolex ER tablet releases amantadine throughout the day.
Learn more about Osmolex ER tablets
The FDA approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication
for adult patients living with HIV who have tried multiple HIV medications in
the past (heavily treatment-experienced) and
whose HIV infections cannot be successfully treated with other currently
available therapies (multidrug-resistant
HIV). Trogarzo is administered intravenously once every 14 days by a trained
medical professional and used in combination with other antiretroviral
Learn more about Trogarzo
The FDA approved ZTlido (lidocaine topical system) 1.8%, a non-opioid stick-on patch to relieve nerve pain due to shingles. ZTlido is based on new technology that allows for superior adhesion and drug delivery. ZTlido requires a 36mg topical system compared with a 700mg patch of Lidoderm (lidocaine patch 5%) to achieve the same dose.
Learn more about ZTlido
FDA New Combinations
Cimduo (lamivudine and tenofovir disoproxil fumarate) 300mg/300mg tablets is a once-daily combination of two nucleo(t)side reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35kg.
Learn more about Cimduo
FDA New Indications
Adcetris (brentuximab vedotin) is now approved to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. Adcetris combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30. Adcetris has also been previously approved by the FDA to treat cHL after relapse, cHL after stem cell transplant when a patient is at a high risk of relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after failure of other treatment, and primary cutaneous ALCL after failure of other treatment.
Learn more about Adcetris
CSL Behring announced that the FDA approved Hizentra (immune globulin subcutaneous [human] 20% liquid) as the first and only subcutaneous immunoglobulin for the treatment of chronic inflammatory demyelinating polyneuropathy as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
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The FDA expanded approval of Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are unresectable and whose cancer has not progressed after treatment with chemoradiation. The immunotherapy is the first treatment approved to reduce the risk of the cancer progressing in this setting.
Learn more about Imfinzi
The FDA has approved a supplemental new drug application for Latuda (lurasidone) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) in children and adolescents aged 10 to 17 years. Latuda is already approved in the US for the treatment of adults with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate, and for the treatment of schizophrenia in adults and in children aged 13 to 17 years.
Learn more about Latuda
Luzu Cream, 1%
Ortho Dermatologics, a division
of Valeant Pharmaceuticals North America, announced that the FDA approved the
supplemental new drug application to expand the use of Luzu (luliconazole)
cream, 1% for the topical treatment of patients 12 and older with athlete's
foot (interdigital tinea pedis) and jock itch (tinea cruris) and patients two
and older with ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum.
Learn more about Luzu Cream
Otonomy, Inc. announced that the FDA has approved Otiprio (ciprofloxacin otic suspension) 6% for
the treatment of acute otitis externa (AOE) in patients 6 months of age and older due to Pseudomonas
aeruginosa and Staphylococcus aureus.
Otiprio is the first single-dose
antibacterial approved by the FDA for treating AOE. Otiprio is also approved for the treatment of pediatric patients 6 months of age and older with bilateral otitis media with effusion undergoing
tympanostomy tube placement.
Learn more about Otiprio
The FDA approved Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. The recommended starting dose of abemaciclib in combination with an aromatase inhibitor is 150mg twice daily orally with or without food.
Learn more about Verzenio
Alka-Seltzer Plus Products
The FDA is alerting consumers of a voluntary recall of Bayer’s Alka-Seltzer Plus products due to labeling errors. Bayer is voluntarily recalling Alka-Seltzer Plus packages that were sold only in the US at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry's Food Stores, Ralphs, King Soopers and Smith's Food and Drug) after February 9, 2018. The packages can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall. Consumers who purchased packages of Alka-Seltzer Plus that are being recalled should stop using the product immediately.
Learn more about the Alka-Seltzer Plus products recall
Bella All Natural Bella Diet Capsules
Bella All Natural is voluntarily recalling its diet capsules labeled as Bella, Lot Number MFD:10.15.2017 EXP: 10.14.2019, to the consumer level. This recall has been initiated due to presence of sibutramine, an appetite suppressant that was withdrawn from the US market in October 2010 due to safety concerns.
Learn more about the Bella All Natural Bella diet capsules recall
Biogen and AbbVie Zinbryta
Biogen and AbbVie are voluntarily taking Zinbryta (daclizumab) for relapsing multiple sclerosis off the market worldwide because of mounting concerns about safety, including reports of severe liver damage and immune-related conditions.
Learn more about the Biogen and AbbVie withdrawal of Zinbryta
Hospira Hydromorphone HCl Injection
Hospira, Inc. is voluntarily recalling three lots of hydromorphone HCl injection, USP CII 10mg/mL, 1mL in 2mL single dose vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots), to the hospital/institution level. Hospira, Inc. initiated this recall on February 07, 2018 due to the potential that units from these lots may be empty or cracked at the bottom of the glass vial.
Learn more about the Hospira hydromorphone HCl injection recall
Hospira Labetalol Injection
Hospira is voluntarily recalling 3 lots of Labetalol HCl Injection, USP, 100mg/20mL vial (NDC 0409-2267-20), and one lot of Labetalol HCl Injection, USP, Novaplus (NDC 0409-2267-25), to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal.
Learn more about the Hospira labetalol injection recall
PDX Aromatics Kratom Powder
PDX Aromatics, DBA Kraken
Kratom, Phytoextractum, and Soul Speciosa,
has initiated a recall of certain kratom-containing powder products
because it has the potential to be contaminated with Salmonella. The affected powder products are packaged in plastic,
heat-sealed pouches and sold in 28g, 56g, and 112g.
Learn more about the PDX Aromatics kratom powder recall
Sagent Pharmaceuticals, Inc. Methylprednisolone Sodium Succinate Injections
Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of methylprednisolone sodium succinate for injection, USP, 40mg, 125mg, and 1g. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. This recall is due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots. This impurity has not yet been identified.
Learn more about the Sagent Pharmaceuticals, Inc. methylprednisolone sodium succinate recall
Biaxin in Patients with Heart Disease
The FDA is advising caution before prescribing the antibiotic Biaxin (clarithromycin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. The recommendation is based on review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue. As a result, a new warning has been added about this increased risk of death in patients with heart disease and advised prescribers to consider using other antibiotics in such patients.
Learn more about Biaxin in patients with heart disease
Cantrell Drug Company’s Compounded Drug Products
The FDA is alerting healthcare professionals and patients not to use drug products produced by Cantrell Drug Company, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk.
Learn more about Cantrell Drug Company’s compounded drug products
Salmonella Infections Linked to Kratom
The FDA and CDC are
investigating a multistate outbreak of Salmonella infections linked to products
reportedly containing kratom. The CDC
reports that 40 people in 27 states are infected with Salmonella I
4,,12:b:-. Fourteen people have been hospitalized. Interviews with ill people are continuing. So far, 17 of 24 ill people
reported consuming kratom before getting sick.
Learn more about Salmonella infections linked to kratom
Unapproved Erectile Dysfunction Products
The FDA warns consumers not to purchase or use drugs advertised nationwide as a “healthy man alternative to the little blue pill” or “healthy man,” or “the power pill” for erectile dysfunction on broadcast and internet radio platforms such as iHeart Radio, as these drugs have not been approved by the FDA. The FDA confirmed that consumers have received these drugs, without a prescription, which contain 100mg of sildenafil, the active ingredient in Viagra. This is a dangerous dosage strength.
Learn more about unapproved erectile dysfunction products