FDA New Approvals
The FDA has approved Asceniv, an intravenous immune globulin drug product for the treatment of primary humoral immunodeficiency disease in adults and adolescents aged 12 to 17 years. The product will be available for commercial launch during the second half of 2019.
Learn more about Asceniv
The FDA has granted Balversa (erdafitinib) accelerated approval for the treatment of adults with locally advanced or metastatic urothelial carcinoma which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Balversa is the first FGFR kinase inhibitor approved by the FDA.
Learn more about Balversa
The FDA approved Dovato (dolutegravir and lamivudine), a two-drug fixed-dose regimen containing 50mg of dolutegravir and 300mg of lamivudine. Dovato is approved as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.
Learn more about Dovato
The FDA has approved Duaklir (aclidinium bromide and formoterol fumarate) inhalation. Duaklir is a fixed-dose combination of aclidinium bromide 400mcg and formoterol fumarate 12mcg for the maintenance treatment of chronic obstructive pulmonary disease. The combination is administered twice daily via the breath-actuated inhaler, Pressair.
Learn more about Duaklir
The FDA approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of fracture. These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies. A full course of Evenity therapy is 12 monthly doses administered by a healthcare provider.
Learn more about Evenity
The FDA has approved Jatenzo (testosterone undecanoate), an oral testosterone capsule for treatment of men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland. Jatenzo should not be used to treat men with “age-related hypogonadism,” even if these men have symptoms that appear to be related to low testosterone. Jatenzo’s benefits do not outweigh its risks for that use.
Learn more about Jatenzo
The FDA approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, including relapsing-remitting disease and active secondary progressive disease. Mavenclad is not recommended for MS patients with clinically isolated syndrome. Because of its safety profile, the use of Mavenclad is generally recommended for patients who have had an inadequate response to or are unable to tolerate an alternate drug indicated for the treatment of MS.
Learn more about Mavenclad
The FDA has approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive multiple sclerosis. Patients will not require a first dose observation unless they have certain preexisting cardiac conditions.
Learn more about Mayzent
The FDA approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Once-daily Sunosi is approved with doses of 75mg and 150mg for patients with narcolepsy and doses of 37.5mg, 75mg, and 150mg for patients with OSA. Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat excessive daytime sleepiness in adults living with narcolepsy or OSA.
Learn more about Sunosi
The FDA has approved the reintroduction of Zelnorm (tegaserod) oral tablets for irritable bowel syndrome with constipation in women younger than age 65. Zelnorm was pulled from the market in 2007 because of patient safety concerns.
Learn more about Zelnorm
The FDA approved Zulresso (brexanolone) injection for intravenous use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD. Zulresso will be available only through a restricted program called the Zulresso REMS Program that requires the drug be administered by a healthcare provider in a certified healthcare facility.
Learn more about Zulresso
FDA First-Time Generic Approvals
Naloxone Nasal Spray
The FDA has granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.
Learn more about naloxone nasal spray
FDA New Indications
The FDA approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first time that the FDA has approved a treatment for nr-axSpA.
Learn more about Cimzia
The FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in male patients.
Learn more about Ibrance
The FDA approved Keytruda (pembrolizumab) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (tumor proportion score ≥1%) as determined by an FDA-approved test.
Learn more about Keytruda
The FDA approved Tecentriq (atezolizumab) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer.
Learn more about Tecentriq
Ata Int. Inc. Bluefusion Capsules
Ata Int. Inc. is voluntarily recalling all lots within expiry of Bluefusion capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein. Bluefusion capsules were marketed as a dietary supplement for male enhancement and are packaged in 1-count blister packs, UPC – 7.48252.66460.0. All lots within expiry are being recalled. Product was distributed nationwide in the US between January 2015 and March 2019 to retail stores and through the internet.
Learn more about the Ata Int. Inc. Bluefusion capsules recall
Hospira, Inc. Sodium Bicarbonate 8.4% Injection
Hospira, Inc. is voluntarily recalling lot numbers 79-238-EV, 79-240-EV, and 80-088-EV, NDC# 0409-6625-02, of 8.4% sodium bicarbonate injection USP, 50mEq/50mL (1mEq/mL), to the hospital/institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass.
Learn more about the Hospira, Inc. sodium bicarbonate injection recall
Kingston Pharma DG/Health Naturals Baby Cough Syrup + Mucus
Kingston Pharma is recalling Lot KL180157 of its 2-fluid ounce (59mL) bottles of DG/Health Naturals Baby Cough Syrup + Mucus because it has the potential to be contaminated with Bacillus cereus/Bacillus circulans.
Learn more about the Kingston Pharmacy DG/health Naturals Baby Cough Syrup + Mucus recall
Legacy Pharmaceutical Packaging Losartan 25mg, 50mg, 100mg Tablets
Legacy Pharmaceutical Packaging is recalling 40 repackaged lots of losartan tablets USP 25mg (NDC 68645-577-54), 50mg (NDC 68645-578-54), and 100mg (NDC 68645-579-54) to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a voluntary nationwide recall of losartan tablets, USP, due to the detection of trace amounts of N-Nitroso-N-methyl-4-aminobutyric acid, a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited.
Learn more about the Legacy Pharmaceutical Packaging losartan tablets recall
Mylan Institutional Levoleucovorin 250mg/25mL Injection
Mylan Institutional is conducting a voluntary nationwide recall of two lots (APB032, APB033) of levoleucovorin injection, 250mg/25mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional. The levoleucovorin injection is being recalled due to the presence of particulate matter identified as copper salts. The particulate matter was discovered during 12-month stability testing.
Learn more about the Mylan Institutional levoleucovorin injection recall
SD Import Aphrodisiac Capsules
SD Import is voluntarily recalling all lots of aphrodisiac capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. The presence of sildenafil in aphrodisiac capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Learn more about the SD Import aphrodisiac capsules recall
USA LESS Leopard Miracle Honey
USA LESS is voluntarily recalling all lots of Leopard Miracle Honey to the consumer level. FDA analysis has found Leopard Miracle Honey to be tainted with sildenafil.
Learn more about the USA LESS Leopard Miracle Honey recall
Addyi Safety Labeling Change
Based on the results of postmarketing studies, the FDA has determined that changes must be made to Addyi’s labeling to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely. Specifically, the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or should skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime.
Learn more about the Addyi safety labeling change
Harm Reported from Sudden Discontinuation of Opioid Pain Medicines
The FDA has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide. Healthcare professionals should not abruptly discontinue opioids in a patient who is physically dependent.
Learn more about harm reported from sudden discontinuation of opioid pain medicines
The FDA approved multiple generics for Letairis (ambrisentan). With the approval of these first generics, and their associated REMS programs, patients will now have access to additional products (brand-name and generic) and additional types of pharmacies to fill their prescriptions (retail or specialty). The FDA also approved two shared system REMS programs for ambrisentan. There are now two separate REMS programs for ambrisentan. The first is known as the Ambrisentan REMS (formerly called the Letairis REMS) and is comprised of the reference listed drug or brand sponsor (Letairis), as well as three abbreviated new drug applications (ANDAs, or generics). The second program is currently comprised of one ANDA sponsor and is known as the PS-Ambrisentan REMS. The PS signifies “parallel system” to assist in differentiating the programs within the market.
Learn more about Letairis generics
Risks Associated with Investigational Use of Venclexta in Multiple Myeloma
The FDA is alerting healthcare professionals, oncology clinical investigators, and patients about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma based on data from a clinical trial. Venclexta is not approved for the treatment of multiple myeloma. This alert does not apply to patients taking Venclexta for an approved indication. Patients taking Venclexta for an approved indication should continue to take their medication as directed by their healthcare professional.
Learn more about risks associated with investigational use of Venclexta in multiple myeloma
Temporary Distribution of Losartan Allowed
To ensure patient access to losartan, the FDA will not object to certain manufacturers temporarily distributing losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit interim of 0.96 ppm and below 9.82 ppm until the impurity can be eliminated. The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the US supply in approximately six months. Agency scientists evaluated the risk of exposure to NMBA at levels up to 9.82 ppm and determined that it presents no meaningful difference in cancer risk over six months when compared to a lifetime of exposure to NMBA at 0.96 ppm.
Learn more about the temporary distribution of losartan
The FDA approved a new generic of valsartan. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.
Learn more about new generic valsartan