FDA Updates

Rituximab-abbs (Truxima) is the only biosimilar to the reference product rituximab (Rituxan). 

Officials with the FDA have granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy, Immunomedics Inc.) for previously-treated adult patients with metastatic triple-negative breast cancer.

Officials with the FDA today approved tucatinib (Tukysa, Seattle Genetics) in combination with chemotherapy trastuzumab and capecitabine for the treatment of adults with advanced forms of HER2-positive breast cancer.

Merck has announced the US launch of trastuzumab-dttb (Ontruzant), a biosimilar to trastuzumab (Herceptin), in both 150-mg single-dose vials and 420-mg multiple-dose vials.

Officials with the FDA have granted approval to ixekizumab (Taltz, Eli Lilly) injection, 80 mg/mL for the treatment of pediatric patients with moderate-to-severe plaque psoriasis.

Officials with the FDA have approved luspatercept-aamt (Reblozyl, Bristol Myers Squibb and Acceleron Pharma) for the treatment of anemia in adults with lower-risk myelodysplastic syndromes.

Coagulation factor VIIa (recombinant)-jncw (Sevenfact, LBF) contains an active ingredient from a genetically engineered animal.

Bempedoic acid (Nexletol, Esperion), an oral, once-daily, non-statin low-density lipoprotein-cholesterol lowering medicine, is now available in US pharmacies.

As coronavirus cases surge nationwide, retail pharmacies are facing incredibly difficult circumstances.

Officials with the FDA have approved durvalumab (Imfinzi) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), in combination with standard-of-care (SoC) chemotherapies, in adult patients.

Johnson & Johnson expects to initiate human clinical studies for its lead COVID-19 vaccine candidate by September 2020.

Officials with the FDA have granted approval to ozanimod (Zeposia, Bristol Myers Squibb) for the treatment of relapsing multiple sclerosis.

Crisaborole ointment, 2% (Eucrisa, Pfizer) has been approved for use in pediatric patients with atopic dermatitis as young as 3 months of age.

Officials with the FDA have approved a 420-mg multi-dose of trastuzumab-bttb (Ontruzant, Samsung Bioepis), a biosimilar referencing trastuzumab (Herceptin).

The FDA issued emergency use authorization of a rapid, point-of-care COVID-19 diagnostic test, developed by Cepheid, that has a detection time of approximately 45 minutes.

Analysts have forecasted the market for NASH drugs could reach $20 billion by 2025.

Dr. Reddy’s Laboratories has launched its ziprasidone mesylate 20 mg/mL for injection, the first generic version of Geodon (Pfizer) for injection. 

On December 23, 2019, the FDA approved ubrogepant for the acute treatment of migraine with and without aura in adult patients.

Empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) is being investigated to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.

Nintedanib (Ofev, Boehringer Ingelheim Pharmaceuticals) has been approved for the treatment of chronic fibrosing interstitial lung disease with a progressive phenotype.

Advil Dual Action, an ibuprofen and acetaminophen fixed-dose combination, has been approved as an OTC product for pain relief.

Pyrimethamine (Daraprim) tablets are used to treat toxoplasmosis.

Rimegepant (Nurtec ODT, Biohaven),a fast-acting orally disintegrating tablet, delivers quick and sustained efficacy for patients with migraine.

Bempedoic acid (Nexletol, Esperion) is a new lipid-lowering therapy option for patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease.

Eptinezumab-jjmr (Vyepti, Lundbeck) decreased mean monthly migraine days in adult patients in 2 phase 3 clinical trials.

Despite sickle cell disease's (SCD) lower profile, 3 new SCD drugs were approved in the last 3 years, with 2 approvals occurring in late 2019

Solid recommendations can require detective work. 

Genentech announced new 1-year data from the SUNFISH trial evaluating risdiplam in spinal muscular atrophy.

A supplemental application for cannabidiol oral solution (Epidiolex, GW Pharmaceuticals and Greenwich Biosciences) has been submitted for the treatment of seizures associated with tuberous sclerosis complex.