This column summarizes New Drug Applications (NDAs) approved from July-August 2016. FDA approved 21 NDAs in these two months.
Thirteen (61.9%) NDAs were for small molecules while the remaining eight (38.1%) were large molecules. Pfizer and GlaxoSmithKline were the only companies with two NDA approvals in this period. Three out of 21 (14.3%) of NDAs were combination dosage forms. Three out of 21 NDA’s were for treatment of various types of cancers, while two of each NDA’s were for the treatment of diabetes Type 2, and prophylaxis. The types of dosage forms approved were – tablets and capsules: six (27.3%), injections: eleven (50.0%), oral solutions: two (9.1%), Ophthalmic solutions: one (4.5%), topical gels: one (4.5%), and nasal sprays: one (4.5%). Salix Pharmaceuticals obtained approval for Relistor in both forms – tablets and injection.
Xiidra is the first medication in a new class of drugs called lymphocyte function-associated antigen 1, which is approved by the FDA for dry eye disease. FDA approved Amgen’s Repatha for the treatment of Heterozygous familial hypercholesterolemia.
FDA approved Prevnar 13 for pneumococcal disease prophylaxis with expanded age indication to include adults 18 through 49 years of age.
Qbrelis is the first and only FDA approved Lisinopril oral solution, 1 mg/mL. There are several Lisinopril tablets already approved. The company has been awarded patent # 9463183, which expires in 2035. The approved independent claim state - a stable oral liquid formulation, comprising: (i) about 1 mg/ml lisinopril or a pharmaceutically acceptable salt or solvate thereof; (ii) about 150 mg/ml of a sweetener that is xylitol; (iii) a buffer comprising about 0.86 mg/ml citric acid and about 1.44 mg/ml sodium citrate; (iv) about 0.8 mg/ml of a preservative that is sodium benzoate; and (v) water; wherein the pH of the formulation is between about 4 and about 5; and wherein the formulation is stable at about 25°±0.5°C for at least 12 months.
FDA approved Arena Pharmaceuticals’ Belviq for obesity as once a day dosing option. Belviq (lorcaserin) affects chemical signals in the brain that control appetite. Lorcaserin works by helping you feel full with smaller meals. Belviq is used together with diet and exercise to treat obesity. Adlyxin is available in a disposable pre-filled pen in a single dose of 20 micrograms for diabetes Type 2. Adlyxin is a once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with Type 2 diabetes mellitus as an adjunct to diet and exercise. Aflria is an influenza virus vaccine developed by CSL Biotherapies and it is available in prefilled syringes and multi-dose vials.
GlaxoSmithKline’s Arzerra was approved for Chronic Lymphocytic Leukemia (CLL) under priority review. It is directed in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate; in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL; for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL; and for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.