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New Drug Approvals Archive - June 2021

See also: New Indications and Dosage Forms for June 2021

June 2021

Brexafemme (ibrexafungerp) Tablets

Date of Approval: June 1, 2021
Company: Scynexis, Inc.
Treatment for: Vaginal Candidiasis

Brexafemme (ibrexafungerp) is a first-in-class, triterpenoid antifungal agent for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC).

Wegovy (semaglutide) Injection

Date of Approval: June 4, 2021
Company: Novo Nordisk
Treatment for: Obesity

Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise for chronic weight management in adult patients who are overweight (BMI ≥27 kg/m2) or obese (BMI ≥30 kg/m2).

Ryplazim (plasminogen, human-tvmh) Injection

Date of Approval: June 4, 2021
Company: Liminal BioSciences Inc.
Treatment for: Plasminogen Deficiency Type 1

Ryplazim (plasminogen, human-tvmh) is a plasma-derived plasminogen replacement therapy for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia).

Tembexa (brincidofovir) Tablets and Oral Suspension

Date of Approval: June 4, 2021
Company: Chimerix, Inc.
Treatment for: Smallpox

Tembexa (brincidofovir) is a nucleotide analog broad-spectrum antiviral indicated for use as a medical countermeasure for smallpox.

Aduhelm (aducanumab-avwa) Injection

Date of Approval: June 7, 2021
Company: Biogen
Treatment for: Alzheimer's Disease

Aduhelm (aducanumab-avwa) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.

This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Prevnar 20 (pneumococcal 20-valent conjugate vaccine) Injection

Date of Approval: June 8, 2021
Company: Pfizer Inc.
Treatment for: Pneumococcal Disease Prophylaxis

Prevnar 20 (pneumococcal 20-valent conjugate vaccine) is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.

Rezipres (ephedrine hydrochloride) Injection

Date of Approval: June 14, 2021
Company: Eton Pharmaceuticals, Inc.
Treatment for: Hypotension

Rezipres (ephedrine hydrochloride) is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

New Drug Approvals Archive

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