Miebo, First Prescription Eye Drop to Treat Tear Evaporation in Dry Eye Disease, Now Available
The perfluorohexyloctane ophthalmic solution from Bausch + Lomb was approved by the FDA in May and will have a whole acquisition cost of $771 for a one-month supply.
First Anti-Inflammatory Drug for Cardiovascular Disease Approved by FDA
Lodoco (colchicine) approval was based on a clinical trial with 5,522 patients with chronic coronary disease, which was published in Circulation in February 2022.
FDA Approves Sotagliflozin For Heart Failure Across Full Range of LVEF
The medication is broadly approved for heart failure with preserved or reduced ejection fraction.
FDA Approves First Oral Treatment for Patients With Moderate to Severe Crohn's Disease
The approval of Rinvoq (upadacitinib) was based on the results of three clinical trials: two induction therapy studies and one maintenance study.
FDA Approves Two Medications for Treatment of Schizophrenia
Otsuka America Pharmaceutical and Lundbeck’s Alify Asimtufii (aripiprazole) also was approved for maintenance monotherapy treatment of bipolar I disorder in adults.
FDA Approves Qalsody, First-of-its-Kind Treatment for Rare Form of ALS
The drug treats amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS).
FDA Approves Ruxolitinib Cream 1.5% to Treat Nonsegmental Vitiligo
Ruxolitinib (Opzelura) cream is the first and only FDA-approved treatment for patients with vitiligo.
Top Pharmacy Innovations of 2021
From medication to legislation, multiple developments have advanced the
pharmacy profession this year.
Merck, Ridgeback Announce EUA Submission for Investigational Oral Antiviral Molnupiravir for COVID-19
Merck and Ridgeback Biotherapeutics have announced their submission of an EUA application to the FDA for an oral antiviral medication for the treatment of COVID-19.
A Review of FDA-Approved Medications for Chronic Weight Management
Five medications are currently approved by the FDA for chronic weight management.
Fixed-Dose Combo Cream Treatment Approved for Acne Vulgaris
Sol-Gel Technologies has created a single-application acne treatment cream, combining 2 commonly used ingredients: tretinoin and benzoyl peroxide.
FDA OKs Treatment for Adolescents With Type 2 Diabetes
The FDA has approved the AstraZeneca once-weekly injectable therapy for use in children aged 10 to 17 years.
Novel Antifungal Treatment Approved for Vaginal Candidiasis
On June 2,2021, ibrexafungerp (Brexafemme; Scynexis, Inc) was approved by the FDA for vulvovaginal candidiasis (VVC) in adult women and girls who have begun menstruating.
FDA OKs OTC Use of Steroid-Free Antihistamine Allergy Nasal Spray
The FDA has approved OTC azelastine HCl .15% (Astepro Allergy; Bayer).
FDA Approves Pneumococcal 20-Valent Conjugate Vaccine for Adults
The vaccine is indicated to prevent invasive disease and pneumonia caused by 20 Streptococcus pneumoniae serotypes.
FDA OKs Secukinumab for Children Aged 6 and Older
The FDA approved Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis in children aged 6 years and older.
Boost Revenue and Patient Satisfaction With Point-of-Care Testing
In a session from the PDS 2021 Virtual Super-Conference, experts discussed how POC testing capabilities enhance patient services and address antimicrobial resistance.
Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
Melphalan flufenamide (Pepaxto; Oncopeptides AB) in combination with dexamethasone was granted accelerated approval on February 26, 2021, by the FDA for adult patients with relapsed or refractory multiple myeloma.
FDA Grants Accelerated Approval to Dostarlimab for Advanced dMMR Endometrial Cancer
This indication is approved under accelerated approval based on tumor response rate and durability of response.
FDA OKs New Combined Oral Contraceptive
Nextstellis (drospirenone; estetrol) now is approved as a combined oral contraceptive for birth control.
AstraZeneca’s COVID-19 Vaccine Data Show 79% Efficacy Against Symptomatic Disease
AstraZeneca is preparing to submit its COVID-19 vaccine data to the FDA for emergency use authorization in the coming weeks.
FDA Grants Emergency Use Authorization to Third COVID-19 Vaccine
The FDA has granted emergency use authorization status for the first single-dose vaccine for COVID-19 in the United States.
FDA OKs Expanded Indication for Heart Failure Treatment
Novartis’ sacubitril/valsartan (Entresto) is now indicated for use in the treatment of chronic heart failure.
Belantamab mafodotin-blmf for Relapsed or Refractory Multiple Myeloma
Belantamab mafodotin-blmf is now indicated for adult patients with relapsed or refractory myeloma who have received at least 4 prior therapies.
FDA OKs Long-Acting Injectable Drug Regimen for HIV Treatment
Officials with the FDA have approved cabotegravir and rilpivirine, injectable formulation (Cabenuva; ViiV Healthcare) as a complete regimen for the treatment of HIV-1 infection in adults.
Remdesivir in the Treatment of COVID-19
On October 22, 2020, the FDA approved remdesivir (Veklury; Gilead) as the first treatment for coronavirus disease 2019 (COVID-19).
Leukemia, Bladder Cancer Drug Markets Expected to Soar
The market for acute lymphocytic leukemia and bladder cancer drug therapies is expected to soar over the next few years, thanks in part to new and innovative medications.
Top FDA Approvals of 2020
Here are some of the top-read FDA approvals covered by Drug Topics® from this year.
Leucadia Pharmaceuticals Launches Acetaminophen Injection
Acetaminophen injection, 1000 mg/100 mL, is an FDA-approved generic to Ofirmev.
Azacitidine Tablets for Acute Myeloid Leukemia
The FDA approved azacitidine tablets (Onureg; Celgene Corporation) on September 1, 2020
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