FDA New Approvals
The FDA has approved Arazlo (tazarotene) 0.045% lotion to treat acne vulgaris in individuals aged 9 years and older. Arazlo is the first tazarotene acne treatment available in lotion form.
Learn more about Arazlo
The FDA has approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. Ayvakit is the first precision therapy approved to treat a genomically defined population of patients with GIST.
Learn more about Ayvakit
The FDA has approved Caplyta (lumateperone), an atypical antipsychotic, for the treatment of schizophrenia in adults. Caplyta is a first-in-class antipsychotic that acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.
Learn more about Caplyta
The FDA has provided marketing approval for Conjupri (levamlodipine maleate) tablets. Conjupri is indicated for the treatment of hypertension in adults and pediatric patients aged 6 years and older, to lower blood pressure. Conjupri is the first innovative drug in China to be fully approved by the US. The Chinese listing name of Conjupri is Xuanning.
Learn more about Conjupri
The FDA approved Dayvigo (lemborexant) 5mg and 10mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The FDA has recommended classification of Dayvigo as a controlled substance.
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The FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. The prescribing information for Enhertu includes a Boxed Warning to advise healthcare professionals and patients about the risk of interstitial lung disease and embryo-fetal toxicity.
Learn more about Enhertu
The FDA has now approved Genosyl (nitric oxide) gas, for inhalation. Genosyl is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks’ gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. The Genosyl Delivery System is a compact and user-friendly nitric oxide delivery system, designed to reduce the logistical burden within hospitals as compared to the cumbersome tank-based systems currently available, and could provide greater patient access.
Learn more about Genosyl
The FDA approved TissueBlue (brilliant blue G) 0.025% ophthalmic solution. TissueBlue is used as an aid in ophthalmic surgery by selectively staining the internal limiting membrane (ILM). The transparency of the ILM makes it difficult to visualize and peel. TissueBlue is injected onto the inner retinal surface, enabling the ILM to be clearly stained and distinguished from unstained retina, thereby facilitating removal.
Learn more about TissueBlue
The FDA approved Ubrelvy (ubrogepant) tablets for the acute treatment of migraine with or without aura in adults. Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.
Learn more about Ubrelvy
FDA First-Time Generic Approvals
First Eliquis Generics Approved
The FDA has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.
Learn more about the first Eliquis generics approval
FDA New Indications
The FDA has approved the use of Fiasp (insulin aspart injection) 100 units/mL injection, a newer insulin formula combining insulin aspart recombinant and niacinamide, for pediatric patients with diabetes. Fiasp was first approved by the FDA in September 2017 for use by adults and in October 2019 for use in insulin pumps. Fiasp can be administered via multiple daily injections and insulin pumps and is approved for intravenous infusion under supervision by healthcare professionals.
Learn more about Fiasp
The FDA approved Keytruda (pembrolizumab) for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Learn more about Keytruda
The FDA approved Lynparza (olaparib) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Lynparza is already approved for use in BRCA-mutated ovarian and breast cancers.
Learn more about Lynparza
Aurobindo Mirtazapine Tablets
Aurobindo is voluntarily recalling mirtazapine tablets, lot number 03119002A3, to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as mirtazapine 7.5mg may contain 15mg tablets.
Learn more about the Aurobindo mirtazapine tablets recall
Mavidon Manufactured Products
Mavidon is notifying
customers of a voluntary recall of all lots of products manufactured at its facility.
Hospitals and clinics are to
stop using LemonPrep, PediaPrep, Wave Prep, Cardio Prep manufactured by Mavidon
immediately due to potential contamination with Burkholderia cepacia. The recall also
includes Collodions, Collodion Remover, Medical Adhesive Remover, and Acetone.
Learn more about the Mavidon manufactured products recall
Mylan Pharmaceuticals Nizatidine Capsules
Mylan Pharmaceuticals is conducting a voluntary nationwide recall, to the consumer level, of three lots (3086746, 3082876, 3082877) of nizatidine capsules, USP, including the 150mg and 300mg strengths. This product is being voluntarily recalled due to detected trace amounts of an impurity, NDMA, contained in the API nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited.
Learn more about the Mylan Pharmaceuticals nizatidine capsules recall
Taro Pharmaceuticals Lamotrigine Tablets
Taro Pharmaceuticals is voluntarily recalling one lot of lamotrigine 100mg tablets, lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1, to the consumer level. This single lot was found to have been cross-contaminated with a small amount of another drug substance (enalapril maleate) used to manufacture another product at the same facility.
Learn more about the Taro Pharmaceuticals lamotrigine tablets recall
PremierZEN Gold 7000 Contains Hidden Ingredients
The FDA is advising consumers not to purchase or use PremierZEN Gold 7000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that PremierZEN Gold 7000 contains sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis.
Learn more about PremierZEN Gold 7000 containing hidden ingredients
In September 2019, the FDA issued a public statement alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing. The FDA is continuing to alert professionals and patients to voluntary recalls of ranitidine. Additionally, the agency has issued a statement regarding new testing results.
Learn more about ranitidine product recalls and updates
Risk of Serious Breathing Problems with Gabapentin and Pregabalin
The FDA is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease that reduce lung function. The elderly are also at higher risk.
Learn more about the risk of serious breathing problems with gabapentin and pregabalin
The FDA posted a warning letter to Alkermes, Inc. for misbranding the drug Vivitrol (naltrexone) extended-release injection by omitting warnings about the most serious risks associated with the drug from promotional material.
Learn more about the Vivitrol warning