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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Ascor (ascorbic acid injection USP), which is indicated for the short-term (up to 1 week) treatment of scurvy in adults and children aged 5 months and older for whom oral administration is not possible, is insufficient or is contraindicated. Ascor is not indicated for the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. Learn more about Ascor


    The FDA granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. Calquence is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread. Learn more about Calquence


    The FDA has approved Cinvanti (aprepitant) injectable emulsion, for intravenous infusion. Cinvanti is a substance P/neurokinin-1 receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Learn more about Cinvanti


    The FDA has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older and with an eosinophilic phenotype. Learn more about Fasenra


    The FDA approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII inhibitors. Hemlibra is a first-in-class therapy that works by bridging other Factors in the blood to restore blood clotting for these patients. Hemlibra is a prophylactic treatment given weekly via subcutaneous injection. Learn more about Hemlibra


    The FDA has approved Heplisav-B [hepatitis B vaccine, recombinant (adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Heplisav-B is the first new hepatitis B vaccine in the US in more than 25 years and the only two-dose hepatitis B vaccine for adults. Learn more about Heplisav-B


    The FDA has approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is a lysosomal storage disorder caused by deficiency of an enzyme called beta-glucuronidase, which causes an abnormal buildup of toxic materials in the body’s cells. Mepsevii is an enzyme replacement therapy that works by replacing the missing enzyme. Learn more about Mepsevii


    The FDA has approved Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion. Prevymis is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. Learn more about Prevymis


    The FDA has approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses. Learn more about Shingrix


    Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. announced that the FDA approved the NDA for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%). Vyzulta, the first prostaglandin analogue with one of its metabolites being nitric oxide, is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Learn more about Vyzulta


    Yescarta (axicabtagene ciloleucel) has received FDA approval for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma. Learn more about Yescarta

    FDA New Combinations

    Abilify MyCite

    The FDA has approved the first drug in the US with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. Learn more about Abilify MyCite

    FDA First-Time Generic Approvals

    Carvedilol Phosphate Extended-Release Capsules, 10mg, 20mg, 40mg and 80mg

    This new generic for Coreg CR capsules is indicated for the treatment of hypertension. Learn more about carvedilol phosphate

    Dapsone Gel, 5%

    The new generic for Aczone is indicted for the topical treatment of acne vulgaris. Learn more about dapsone

    Methadone Hydrochloride Injection USP, 200mg/20mL (10mg/mL) Multiple Dose Vial

    This new generic is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatment options are inadequate; for use in temporary treatment of opioid dependence in patients unable to take oral medication. Learn more about methadone hydrochloride

    Potassium Chloride for Oral Solution USP, 20mEq

    This new generic for Klor-Con powder is indicted for treatment of potassium deficiency. Learn more about potassium chloride

    Sodium Acetate Injection USP, 400mEq/100mL (4mEq/mL)

    This new generic is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Learn more about sodium acetate

    FDA New Formulations

    Bydureon BCise

    The FDA has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control. Learn more about Bydureon BCise

    Lyrica CR

    The FDA has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. Lyrica CR did not receive approval for the management of fibromyalgia. Learn more about Lyrica CR

    FDA New Indications


    The FDA has approved the Adcetris (brentuximab vedotin) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma and CD30-expressing mycosis fungoides who have received prior systemic therapy. This is the fourth FDA-approved indication for Adcetris. Learn more about Adcetris


    The FDA granted approval to Alecensa (alectinib) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. The FDA also converted Alecensa’s initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line) to a full approval. Learn more about Alecensa


    The FDA has approved Auryxia (ferric citrate) for an additional indication. The approval is for the treatment of iron deficiency anemia in adults with chronic kidney disease, not on dialysis. Auryxia was originally approved in September 2014 for the control of serum phosphorus levels in people with chronic kidney disease who require dialysis. Learn more about Auryxia


    The FDA has approved a new indication for Faslodex (fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy. Learn more about Faslodex


    Genentech announced that the FDA approved Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV). With this approval, Gazyva is available in the US for three different indications across two common types of blood cancer. Learn more about Gazyva


    The FDA has approved Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive. Learn more about Soliris


    The FDA has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Learn more about the Sprycel labeling update


    The FDA has approved Stelara (ustekinumab) for the treatment of patients aged 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The interleukin-12/23 inhibitor was approved in 2009 for the treatment of adults with moderate to severe plaque psoriasis. Learn more about Stelara


    The FDA has approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy. Sutent is a kinase inhibitor that works by blocking several enzymes that promote cell growth. Sutent was first approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma. It is also approved for patients with a certain type of pancreatic cancer. Learn more about Sutent

    Tekturna Oral Pellets

    The FDA has approved Tekturna (aliskiren) Oral Pellets for the treatment of hypertension in adults and children six years of age and older. The new formulation and pediatric indication were approved through the FDA priority review process. The expanded indication for Tekturna provides an additional option for pediatric hypertensive patients, and it provides an alternative dosing option for adults with hypertension. Learn more about Tekturna Oral Pellets


    The FDA expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD. Learn more about Zelboraf

    FDA Recalls

    Baxter Nexterone Injection

    Baxter International Inc. announced it is voluntarily recalling one lot of Nexterone (amiodarone HCl) 150mg/100mL Premixed Injection, distributed between 8/23/2017 and 10/2/2017 to wholesalers/distributors and healthcare facilities, due to the potential presence of particulate matter. Learn more about the Baxter recall

    Fresenius Kabi Midazolam 2mg/2mL Injection

    Fresenius Kabi USA is voluntarily recalling Lot 6400048 of Midazolam Injection, USP, 2mg/2mL packaged in a 2mL prefilled single-use glass syringe, to the hospital/user level. The product mislabeled as Midazolam Injection, USP, 2mg/2mL contains syringes containing and labeled as Ondansetron Injection, USP, 4mg/2mL. Learn more about the Fresenius recall

    Greenstone Diphenoxylate Hydrochloride and Atropine Sulfate Tablets

    Greenstone LLC is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent. Products were distributed nationwide to wholesalers/retailers from November 2016 through June 2017. Learn more about the Greenstone recall

    Octapharma USA Inc. Octagam 10% Intravenous Preparation

    Octapharma USA Inc. is initiating a voluntary market withdrawal of octagam 10% [immune globulin intravenous (human)] 10% Liquid Preparation] that is labeled with lot numbers K724B8541 and K725A8541. Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at the FDA, the most prudent course of action is to suspend further administration of octagam 10% from these particular production lots. Distributors that received these lots of octagam 10% from Octapharma are asked to immediately quarantine these lots and contact Octapharma for return instructions. Learn more about the Octapharma recall

    Ridge Properties DBA Pain Relief Naturally

    Ridge Properties DBA Pain Relief Naturally is voluntarily recalling all lots within expiry of Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine manufactured by Ridge Properties dba Pain Relief Naturally, Salem, Oregon to the consumer level. These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations. Learn more about the Ridge Properties recall

    SCA Pharmaceuticals Injectable Products

    SCA Pharmaceuticals LLC is voluntarily recalling various lots of injectable products to the hospital level. There is a potential for the products to contain microbial contamination. This recall applies to multiple products, including hydromorphone, fentanyl/bupivacaine, morphine, oxytocin/lactated ringers, phenylephrine, calcium gluconate, and rocuronium injectables. See the recall notice for a full list of specific products. Learn more about the SCA Pharmaceuticals recall

    FDA Alerts


    The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009. Learn more about the febuxostat alert

    United Pharmacy Compounding Risk

    The FDA received an adverse event report stating that two patients developed what is described in the report as tissue erosion at the injection site following the administration of an injectable glutamine, arginine and carnitine (GAC) product that was compounded by United Pharmacy, LLC, located in West Palm Beach, Florida. According to the report, a sample of the product was sent for testing and the pH was determined to be above 11. The FDA conducted a for-cause inspection of United Pharmacy and collected samples from two batches of GAC injectable product. Analysis performed on the samples determined the pH to be 10.9, which is alkaline, and no glutamine was detected. Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences. Learn more about the United Pharmacy compounding risk alert