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FDA Approves Kebilidi Gene Therapy for the Treatment of AADC Deficiency

PTC Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy approved in the United States that is directly administered to the brain.

• The gene therapy, which will be marketed in the United States with the brand name Kebilidi™ (eladocagene exuparvovec-tneq), is indicated for the treatment of children and adults with AADC deficiency, including the full spectrum of disease severity.
• AADC deficiency is a highly morbid and life-shortening rare genetic disorder that results in the inability to synthesize dopamine, a neurotransmitter essential for motor function. Kebilidi is a gene replacement therapy that is directly administered to the putamen of the brain through a stereotactic neurosurgical procedure.

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FDA Approves Aucatzyl for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

Autolus Therapeutics plc has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Aucatzyl (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

• Aucatzyl is a CD19-directed genetically modified autologous T cell immunotherapy.
• Aucatzyl is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy).
• ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system, and other organs.

Source: Autolus Therapeutics plc

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Journey Medical has announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. Emrosi was developed in collaboration with Dr. Reddy’s Laboratories Ltd.

• Rosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents
  with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia).
• In two Phase 3 clinical trials, Emrosi demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment treatment success as well as the reduction in total inflammatory lesion count in both studies.

Source: Journey Medical Corporation

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November 2024

Exenatide Injection 300mcg/1.2mL (250mcg/mL) and 600mcg/2.4mL (250mcg/mL)
Approved: November 19, 2024 – Amneal Pharmaceuticals LLC
Treatment for: Type 2 Diabetes
Generic for: Byetta

FDA Approves Orlynvah for the Treatment of Uncomplicated Urinary Tract Infections

Iterum Therapeutics plc announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum.

• Orlynvah is a novel oral penem antibiotic for the treatment of uUTI. Orlynvah possesses potent activity against species of Enterobacterales including those that encode extended spectrum betalactamase (ESBL) or AmpC-type beta-lactamases that confer resistance to third generation cephalosporins.
• There are approximately 40 million uUTI prescriptions generated annually in the United States, and it is estimated approximately 1% of those infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics.

Source: Iterum Therapeutics PLC

FDA Approves Vyalev for Adults Living with Advanced Parkinson’s Disease

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD).

• PD is a progressive and chronic movement disorder resulting in tremor, muscle rigidity, slowness of movement and difficulty with balance resulting from the loss of dopamine-producing brain cells.
• Timing for a patient’s access to Vyalev is dependent on their individual insurance plan. Coverage for Medicare patients is expected in the second half of 2025.
• The majority of adverse reactions (ARs) with Vyalev were non-serious and mild or moderate in
  severity.

Source: AbbVie Inc.

C&A Naturistics is voluntarily recalling all lots of AK Forte, 400mg tablets, to the consumer level. FDA analysis has found the product to be tainted with diclofenac, dexamethasone, and methocarbamol. Products containing diclofenac, dexamethasone, and methocarbamol cannot be marketed as dietary supplements. AK Forte tablets is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

AK Forte is marketed as a dietary supplement for joint pain and arthritis and is packaged in a card box type of packaging, with white, blue, red and gold logo of AK with a gold crown on top with 100 tablets per units, and all codes. C&A Naturistics is notifying its distributors and customers and is arranging for return/replacement etc. of all recalled products.

Consumers with questions regarding this recall can contact the company by phone 619-498-9811 or naturisticsca@gmail.com, Monday through Friday, 10am-7pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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Staska Pharmaceuticals, Inc. is voluntarily recalling one lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence
of glass particulates in one lot of vials used in the production of this batch.

The Ascorbic Acid Solution for Injection is used as a vitamin supplement and is packaged in amber colored vials and the affected lot is SP2400058 with an expiration date of 12/31/2024. The product was distributed nationwide to licensed healthcare providers between 07/31/2024 and 08/27/2024.

The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities, and the presence or absence of vascular anomalies.

To date, Staska Pharmaceuticals has not received any reports of the presence of particulate matter, nor any adverse events related to this recall.

Consumers with questions regarding this recall can contact STASKA PHARMACEUTICALS at 402-782-2207 or 888-801-1370, Monday through Friday, 8am-5pm CDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Source: FDA

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FDA Approves Imuldosa, a Biosimilar to Stelara

Accord BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Imuldosa (ustekinumab-srlf), a biosimilar to Stelara (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The FDA approved Imuldosa for all indications of its reference medicine, Stelara.

• FDA approval of Imuldosa was granted based on a comprehensive clinical development program. The data showed that Imuldosa is similar to its reference product Stelara in terms of pharmacokinetic characteristics, safety, tolerability, efficacy and that Imuldosa adheres to current biosimilar guidance from the FDA.
• Imuldosa has the potential to be an affordable treatment option that provides similar benefits to the current standard of care.

Source: Accord BioPharma

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