FDA New Approvals
The FDA has approved Camcevi (leuprolide mesylate) 42mg, a ready-to-use 6-month subcutaneous depot formulation, as a treatment of advanced prostate cancer.
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The FDA has approved Empaveli (pegcetacoplan), the first targeted C3 therapy for treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Empaveli is approved for use in adults with PNH who are treatment naïve as well as patients switching from the C5 inhibitors Soliris (eculizumab) and Ultomiris (ravulizumab).
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The FDA has approved Lumakras (sotorasib) for the treatment of adult
patients with KRAS
G12C-mutated locally advanced or metastatic non-small cell lung cancer, as
determined by an FDA-approved test, who have received at least one prior
Learn more about Lumakras
The FDA has approved Myfembree (estradiol/norethindrone acetate/relugolix) 1mg/0.5mg/40mg, the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.
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The FDA has approved Nurtec ODT (rimegepant) 75mg for the preventive treatment of migraine. Nurtec ODT is indicated for adult patients with episodic migraine. The approved product label was also expanded to include the use of Nurtec ODT 75mg up to 18 doses/month, allowing for both acute and preventive therapy in the same patient.
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The FDA has approved Pylarify (piflufolastat F 18) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy; or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
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The FDA has approved Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Rybrevant is the first fully human, bispecific antibody approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation.
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The FDA has approved Zeposia (ozanimod) 0.92mg for the treatment of adults with moderately to severely active ulcerative colitis (UC). Zeposia is an oral medication taken once daily and is the first sphingosine 1-phosphate receptor modulator approved for patients with moderately to severely active UC.
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The FDA has approved Zynrelef (bupivacaine/meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. Zynrelef, the first extended-release dual-acting local anesthetic, delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the NSAID meloxicam.
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FDA New Dose Strengths
The FDA has approved a supplemental NDA for a new dose (60mg) of Ingrezza (valbenazine) for the treatment of tardive dyskinesia (TD). Valbenazine is a vesicular monoamine transporter 2 inhibitor indicated for the treatment of adults with TD. The availability of a valbenazine 60mg dose to complement the previously approved doses of 40 and 80mg fills an existing medical need for patients with TD who could benefit from an intermediate dosing option.
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FDA New Indications
The FDA has approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy.
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Dash Xclusive Imperia Elita
Dash Xclusive is voluntarily recalling all lots of Imperia Elita Vitaccino Coffee to the consumer level. FDA analysis has found the product to contain undeclared sibutramine and fluoxetine.
Learn more about the Dash Xclusive Imperia Elita recall
Dibar Nutricional S. de R.L. de C.V. Hand Sanitizer
Dibar Nutricional S. de R.L. De C.V. (Dibar) is voluntarily recalling all Dibar Labs Hand Sanitizer packaged in 8 and 16 fl oz bottles, respectively, to the consumer level. Dibar is also voluntarily recalling ProtectoRx Hand Sanitizer packaged in 2 fl oz and 16 fl oz bottles, respectively, to the consumer level, as well as all Advance Hand Sanitizer packaged in 16 fl oz bottles, likewise, to the consumer level. These products are being recalled after testing revealed the presence of methanol.
Learn more about the Dibar hand sanitizer recall
Durisan Non-Alcohol Hand Sanitizer
Sanit Technologies LLC d/b/a Durisan is updating its previously
announced voluntary recall of Durisan non-alcohol antimicrobial hand sanitizer
products that became contaminated with a common municipal water supply-borne
Learn more about the Durisan non-alcohol hand sanitizer recall
Global Sanitizers Medically Minded Hand Sanitizers
Global Sanitizers is recalling Medically Minded Hand Sanitizers lots E332020, E212020, E082020, E372020, and GV4420205, all with a best by date of 5/21/2022. This recall has been initiated due to the presence of undeclared methanol.
Learn more about the Global Sanitizers Medically Minded Hand Sanitizers recall
Hi Tech Pharmaceuticals Lipodrene
Hi-Tech Pharmaceuticals is recalling Lot # 001211197, Exp. 12/25 of Lipodrene w/ 25mg Ephedra Extract Dietary Supplement due to the presence of 1,4-dimethylamylamine.
Learn more about the Hi Tech Pharmaceuticals Lipodrene recall
Hospira Bupivacaine HCl and Lidocaine HCl
Hospira is voluntarily recalling lot EG6023 of 0.5% bupivacaine HCl injection, USP 30mL and lot EG8933 of 1% lidocaine HCl Injection, USP 30mL, to the hospital/institution level due to mislabeling whereby a portion of each lot was incorrectly labeled as the other product.
Learn more about the Hospira bupivacaine HCl and lidocaine HCl recall
Hospira Sterile Water for Injection
Hospira is voluntarily recalling lot DN9185 of sterile water for injection, USP, 100mL single-dose glass flip-top vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.
Learn more about the Hospira sterile water for injection recall
Miracle8989 PremierZen Gold 7000, PremierZen Platinum 8000, and MaxxZEN Platinum 12000 Capsules
Miracle8989 is voluntarily recalling all lots PremierZen Gold 7000, PremierZen Platinum 8000, and MaxxZEN Platinum 12000 capsules to the consumer level. FDA analysis has found the products to contain undeclared sildenafil and tadalafil.
Learn more about the Miracle8989 PremierZen Gold 7000, PremierZen Platinum 8000, and MaxxZEN Platinum 12000 capsules recall
Novo Nordisk Levemir, Tresiba, Fiasp, Novolog, and Xultophy
Novo Nordisk is voluntarily recalling 1468 product samples of Levemir, Tresiba, Fiasp, Novolog, and Xultophy, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements. This recall only impacts product samples and does not impact product that has been broadly distributed to pharmacies or mail-order services.
Learn more about the Novo Nordisk Levemir, Tresiba, Fiasp, Novolog, and Xultophy recall
Scentsational Soaps & Candles Hand Sanitizers
Scentsational Soaps & Candles has voluntarily expanded its April 27 recall of scented hand sanitizers to include three lots of Goose Creek hand sanitizer (NDC 75078-004) + Aloe and one lot of Coco TKO hand sanitizer in 3.38 and 3.4 fl oz spray bottles, respectively, to the consumer level. These products are being recalled after testing revealed the presence of methanol, benzene, and acetaldehyde.
Learn more about the Scentsational Soaps & Candles hand sanitizers recall
Yamtun7 Poseidon Platinum 3500
Yamtun7 is voluntarily recalling all lots of Poseidon Platinum 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil and sildenafil.
Learn more about the Yamtun7 Poseidon Platinum 3500 recall
The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. PBC is a rare, chronic disease affecting the ducts in the liver that carry bile, which helps with digestion. Some PBC patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure, sometimes requiring liver transplant.
Learn more about Ocaliva