Last year, the FDA approved largest number of generic approvals ever in a single year and saw the largest number of New Molecular Entities (NMEs) approved since 1996 (46).
That pace hasn’t slowed in 2018. As of this writing, the FDA has already approved 43 NMEs, putting it well above even last year’s blistering pace. This year’s approvals are wide-ranging, from new cancer medications to cannabis-based products to the first new pain management medication for endometriosis in a decade to the first treatment for smallpox.
Here’s what you need to know about all of the NMEs since June, the last time we covered the FDA’s output.
Moxidectin (Medicines Development for Global Health)
Indications: The treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older.
Dosage: 8 mg (four 2 mg tablets) as a single oral dose, with or without food.
Indications: The radical cure (prevention of relapse) of Plasmodium vivax malaria in patients 16 years and older receiving appropriate antimalarial therapy for acute P. vivax infection.
Dosage: Single dose of 300 mg administered as two 150-mg Krintafel tablets taken together.
Contraindications: G6PD deficiency or unknown G6PD status. Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown. Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of Krintafel.
Indications: The management of moderate to severe pain associated with endometriosis.
Dosage: 150 mg once daily for up to 24 months or 200 mg twice daily for up to 6 months for patients with little no hepatic impairment, 150 mg once daily for up to 6 months for patients with moderate hepatic impairment.
Contraindications: Pregnancy, known osteoporosis, severe hepatic impairment, strong organic anion transporting polypeptide (OATP) 1B1 inhibitors.
Indications: A source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
Dosage: The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day.
Contraindications: Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients. Severe hemorrhagic disorders. Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides greater than 1,000 mg/dL.
Indications: The treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
Dosage: 0.04 mg/kg as an intravenous infusion over 30 minutes on Days 1, 3, and 5 of each 28-day cycle.
Indications: The treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies, or relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.
Indications: The first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.