This quarterly review on New Drug Applications (NDAs) contains data for applications approved for the first-time during July-September 2020, which includes New Molecular Entities (NMEs) and new biologics. A total of 36 applications were approved by the FDA during these three months.
Following are the percentage of various dosage forms in this quarter-13.9% tablets, 11.1% oral liquids, 47.2% injectables, 5.6% capsules, 8.3% topical, and 13.9% other dosage forms. Other dosage forms include - ophthalmic drops, gas inhalation, metered dose aerosol and implants. Based on the submission classification, the NDAs can be divided as follows: new molecular entity (Type 1) – 40.7%, new active ingredient (Type 2) – 3.7%, new dosage form (Type 3) – 22.2%, new combination (Type 4) – 11.1% and new formulation or manufacturer (Type 5) – 22.2%.
Tralement™ is the first and only FDA approved multi-trace element injection. Each mL contains zinc 3 mg, copper 0.3 mg, manganese 55 mcg and selenium 60 mcg. Tralement™ is recommended only for patients who require supplementation with all four of the individual trace elements (i.e., zinc, copper, manganese, and selenium).
Cellulite is the dimpled-looking skin that commonly occurs in the thigh region. It forms when fatty tissue deep in the skin pushes up against connective tissue. It is estimated that more than 85 percent of all women 21 years and older have cellulite. Qwo™ contains collagenase clostridium histolyticum-aaes and it is the first treatment for cellulite.
Ptosis is when the upper eyelid droops over the eye. The eyelid may droop just a little, or so much that it covers the pupil. Ptosis can limit or even completely block normal vision. Upneeq contains oxymetazoline HCl and it is the only treatment approved to treat Ptosis.
Abametapir is a novel pediculicidal metalloproteinase inhibitor used to treat infestations of head lice. The life cycle of head lice (Pediculus capitis) is approximately 30 days, seven to twelve of which are spent as eggs laid on hair shafts near the scalp. Several metalloproteinase enzymes are critical to the egg hatching and survival of head lice, and abametapir is an inhibitor of these metalloproteinase enzymes (Xeglyze). The improved ovicidal activity (90-100% in vitro) of abametapir allows for a single administration, in contrast to many other topical treatments.
FDA granted accelerated approval to Viltepso® injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is susceptible to exon 53 skipping. DMD is a rare genetic disorder. It is the most common type of muscular dystrophy. DMD is caused by mutations in the DMD gene that results in an absence of dystrophin, a protein that helps keep muscle cells intact. Viltolarsen is an antisense oligonucleotide drug that binds to exon 53 of dystrophin premRNA and excludes the exon in patients with genetic mutations susceptible to exon 53 skipping during mRNA processing. Exon 53 skipping is intended to allow the production of an internal dystrophin protein in patients with genetic mutations susceptible to exon 53.
Alkindi Sprinkle is the first and only FDA-approved granular hydrocortisone formulation for the treatment of Pediatric Adrenocortical Insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not produce adequate amounts of cortisol and is often caused by Addison’s disease or Congenital Adrenal Hyperplasia (CAH). Insufficient levels of cortisol in children may cause delayed or stunted physical development, reproductive irregularities, and can be potentially fatal.