FDA Actions in Brief
FDA granted 2 additional indications for rituximab (Rituxan, Genentech/Biogen Idec) in the treatment of patients with CD-20-positive, B-cell non-Hodgkin's lymphoma (NHL). The agent is now approved as first-line treatment of previously untreated patients with follicular NHL in combination with cyclophosphamide, vincristine, and prednisolone (CVP) chemotherapy, and in the treatment of patients with low-grade NHL with stable disease, or in those with partial or complete response following first-line treatment with CVP chemotherapy.
FDA granted 2 additional indications for rituximab (Rituxan, Genentech/Biogen Idec) in the treatment of patients with CD-20-positive, B-cell non-Hodgkin's lymphoma (NHL). The agent is now approved as first-line treatment of previously untreated patients with follicular NHL in combination with cyclophosphamide, vincristine, and prednisolone (CVP) chemotherapy, and in the treatment of patients with low-grade NHL with stable disease, or in those with partial or complete response following first-line treatment with CVP chemotherapy.
Desonide 0.05% foam (Verdeso, Connetics) was approved for the treatment of mild-to-moderate atopic dermatitis in adults and children.
Drospirenone 3 mg/ethinyl estradiol 20 mcg (Yaz, Berlex) received approval for the treatment of premenstrual dysphoric disorder (PMDD).
FDA approved fentanyl buccal tablets (Fentora, Cephalon) for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
The combination biskalcitrate, metronidazole, and tetracycline capsule (Pylera, Axcan Pharma) was approved for the eradication of Helicobacter pylori. H pylori has been recognized as the main cause of gastric and duodenal ulcers.
FDA approved lamotrigine (Lamictal, GlaxoSmithKline) for the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients aged 2 years and older.
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
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FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
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