The FDA has approved Anjeso (meloxicam) injection for the treatment of moderate to severe pain in adults, either by itself of with other nonsteroidal anti-inflammatory drug analgesics. Anjeso injection will be given as a once-daily intravenous bolus push.
Learn more about Anjeso
The FDA has approved Audenz (influenza A [H5N1]
monovalent vaccine, adjuvanted), the first and only adjuvanted, cell-based
pandemic vaccine to provide active immunization against the influenza A virus,
H5N1 strain. Audenz is indicated for use in individuals aged 6 months and older.
It is designed to be rapidly deployed and can be stockpiled for first
responders in the event of a pandemic.
Learn more about Audenz
The FDA has approved Barhemsys (amisulpride) injection for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults. Barhemsys injection is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed prior prophylaxis using current standard of care.
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The FDA has approved Durysta (bimatoprost) implant, the first intracameral biodegradable sustained-release implant designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The implant delivers 10µg of bimatoprost, a prostaglandin analogue. It comes in a preloaded, single-use applicator to facilitate the administration directly into the anterior chamber of the eye. Its use should be limited to a single implant per eye without retreatment.
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The FDA has approved Fluad Quadrivalent (influenza vaccine, adjuvanted) to protect adults aged 65 years or older against seasonal influenza. Fluad Quadrivalent uses the same MF59 adjuvant as Seqirus's trivalent Fluad vaccine. The adjuvant is designed to generate a strong, broad, durable immune response.
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The FDA approved Isturisa (osilodrostat) oral tablets for adults with Cushing's disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. Cushing's disease is a rare disease in which the adrenal glands make too much of the cortisol hormone. Isturisa is the first FDA-approved drug to directly address this cortisol overproduction by blocking the enzyme known as 11-beta-hydroxylase and preventing cortisol synthesis.
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The FDA approved Nexletol (bempedoic acid), an adenosine triphosphate-citrate lyase inhibitor indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Nexletol is an oral once-daily non-statin medication.
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The FDA approved Nexlizet (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-C, lowering medicine. Nexlizet is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. The effect of Nexlizet on cardiovascular morbidity and mortality has not been determined. Nexlizet is the first non-statin, LDL-C lowering combination medicine ever approved.
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The FDA has approved Nurtec (rimegepant) ODT, the first calcitonin gene-related peptide receptor antagonist available in a fast-acting orally disintegrating tablet for the acute treatment of migraine in adults.
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The FDA has provided final approval for the novel product Pemfexy (pemetrexed for injection), a branded alternative to Alimta. Pemfexy is a ready-to-dilute formulation for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in combination with cisplatin; locally advanced or metastatic nonsquamous NSCLC in patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy as a single agent; and malignant pleural mesothelioma in patients whose disease is unresectable or who are otherwise not candidates for curative surgery, in combination with cisplatin.
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The FDA has approved Pizensy (lactitol) for treatment of chronic idiopathic constipation (CIC). Pizensy is an osmotic laxative indicated for the treatment of CIC in adults. The recommended dosage is 20g orally daily.
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The FDA approved Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa, administered through intravenous infusion, is a CD38-directed cytolytic antibody that works by helping certain cells inthe immune system attack multiple myeloma cancer cells.
Learn more about Sarclisa
The FDA has approved Twirla (levonorgestrel and
ethinyl estradiol) transdermal contraception in women whose body mass index
(BMI) is <30kg/m2
and for whom a combined hormonal contraceptive is appropriate. Applied weekly
to the abdomen, buttock, or upper torso (excluding the breasts), Twirla
delivers a 30µg
daily dose of ethinyl estradiol and 120µg daily dose of levonorgestrel.
Learn more about Twirla
Voltaren Arthritis Pain, Pataday Twice Daily Relief, and Pataday Once Daily Relief
The FDA approved three drugs for nonprescription, or OTC, use through a process called a prescription (Rx)-to-OTC switch. The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain; Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, or dander, for nonprescription use.
Learn more about Voltaren Arthritis Pain, Pataday Twice Daily Relief, and Pataday Once Daily Relief
The FDA has recently approved Vyepti (eptinezumab-jjmr), the first IV calcitonin gene-related peptide blocker for migraine prevention in adults. Vyepti is a 30-minute IV infusion given once every 3 months.
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American Health Packaging Ranitidine Tablets
American Health Packaging has voluntarily recalled eleven lots of ranitidine tablets, USP 150mg, 100 count unit dose blisters due to the potential NDMA amounts above levels established by the FDA. This recall was initiated in response to the recall by the manufacturer Amneal Pharmaceuticals, LLC, which included affected lots that were repackaged by American Health Packaging.
Learn more about the American Health Packaging ranitidine tablets recall
Hikma Pharmaceuticals USA Inc. Ketorolac Tromethamine Injection
Hikma Pharmaceuticals USA Inc., formerly known as West-Ward Pharmaceuticals Corp, is voluntarily extending its previously-announced recall of certain lots of ketorolac tromethamine injection USP 30mg/mL, 1mL fill/2mL vials to the medical facility and retail levels. The product is being recalled due to the presence of small visible particulate matters of a gelatinous/oily nature that appear black in some of the recalled lots.
Learn more about the Hikma Pharmaceuticals USA Inc. ketorolac tromethamine injection recall
Med Man Up2 and Bow & Arrow Supplements
The Med Man Distribution recall of Up2 on from November 8, 2019 has been expanded to include all lots of dietary supplement Bow & Arrow libido enhancer for men. FDA laboratory analysis found Up2 and Bow & Arrow to contain undeclared sildenafil.
Learn more about the Med Man Up2 and Bow & Arrow recall
Salud Natural Entrepreneur, Inc. Nopalina Products
Salud Natural Entrepreneur,
Inc.is voluntarily recalling Nopalina Flax Seed Fiber (powder) and Nopalina
Flax Seed Fiber (capsule) products due to possible Salmonella contamination in one of the
ingredients used in the formula of Nopalina Flax Seed Fiber. The company has
ceased the use of the suspect ingredient.
Learn more about the Salud Natural Entrepreneur, Inc. Nopalina products recall
Taro Pharmaceuticals U.S.A., Inc. Phenytoin Oral Suspension
Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling two lots of phenytoin oral suspension USP, 125mg/5mL both in 237mL bottles, to the consumer level, because the suspension may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing. Phenytoin oral suspension USP, 125mg/5mL is packaged in amber plastic bottles with an inner seal and a white childproof closure.
Learn more about the Taro Pharmaceuticals U.S.A., Inc. phenytoin oral suspension recall
The FDA is advising consumers not to purchase or use Alpha-Male, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that Alpha-Male contains sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction.
Learn more about the Alpha-Male alert
Belviq/Belviq XR to be Withdrawn
The FDA has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the US market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai, has submitted a request to voluntarily withdraw the drug.
Learn more about the Belviq / Belviq XR withdrawal
Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent Novel Coronavirus Disease 2019 (COVID-19)
The FDA and the FTC issued warning letters to seven companies for selling fraudulent COVID-19 products. These products are unapproved drugs that pose significant risks to patient health and violate federal law. The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak. The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat COVID-19.
Learn more about the Coronavirus update regarding warning about fraudulent products
Montelukast Boxed Warning
The FDA is strengthening existing warnings about serious behavior and mood-related changes with Singulair (montelukast) and generics, which is a prescription medicine for asthma and allergy. They are taking this action after a review of available information led to reevaluation of the benefits and risks of montelukast use. Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, the FDA decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate.
Learn more about the FDA strengthening box warning on montelukast
OrgaZEN Gold 5800
The FDA is advising consumers not to purchase or use OrgaZEN Gold 5800. FDA laboratory analysis confirmed this product contains sildenafil, the active ingredient in Viagra. OrgaZEN Gold 5800 has been promoted and sold for sexual enhancement on various websites and possibly in some retail stores.
Learn more about the OrgaZEN Gold 5800 alert
The FDA is advising consumers not to purchase or use Rmflex, a product promoted and sold for joint pain and arthritis on various websites and possibly in some retail stores. FDA laboratory analysis confirmed Rmflex contains diclofenac, a nonsteroidal anti-inflammatory drug.
Learn more about the Rmflex advisory
XXX Platinum WOODIE
The FDA is advising consumers not to purchase or use XXX Platinum WOODIE, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that XXX Platinum WOODIE contains sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction.
Learn more about the XXX Platinum WOODIE alert