Formulary Watch |

Elixir Launches Specialty Generic Program

FDA Grants Priority Review for Novel Immunotherapy for Follicular Lymphoma

If approved, mosunetuzumab could be the first T-cell engaging bispecific antibody for the treatment of any type of non-Hodgkin’s lymphoma. The FDA has assigned a PDUFA date of Dec. 29, 2022.

FDA Grants Priority Review for Lecanemab for Alzheimer’s Disease

FDA Convenes Advisory Committee for the Second Time for ALS Therapy

The Peripheral and Central Nervous System Drugs Advisory Committee will meet for a second time in September 2022 to discuss new analysis of the data for AMX0035 for the treatment of patients with amyotrophic lateral sclerosis.

U.S. Hikes Purchases of COVID-19 Vaccine, Treatment

FDA Approves Obesity Drug for Adolescents

Qsymia is only available through a Risk Evaluation and Mitigation Strategy (REMS) program because of the increased risk for birth defects.

Removing Prior Authorization Can Increase Access to Opioid Use Treatments

The removal of prior authorizations for buprenorphine for use in opioid use disorder was associated with a statistically significant increase in the number of prescriptions filled among Medicaid populations in Illinois but not in California, which had already been seeing an increase in use of such therapies.

UPDATED: CVS Caremark Drops Several Products from Drug List

FDA Extends Review of Diabetes Therapy Teplizumab

The new PDUFA date is Nov. 17, 2022. If approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes.

FDA Declines EUA Request for Zyesami for COVID-19

NRx Pharmaceuticals had been seeking emergency use for Zyesami for COVID-19 respiratory failure. The company will now focus on clinical research for its therapy for patients with bipolar disorder.

FDA Warns about Risk of Death from Copiktra

Final results from a phase 3 study found that Copiktra was associated with a higher risk of serious side effects, dose modifications, and deaths compared with Kesimpta.

Pfizer Submits NDA for Paxlovid For COVID-19

The submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated people at high risk for progression to severe illness from COVID-19.

Alfasigma Withdraws Zelnorm from Market

Zelnorm is used to treat adult women less than 65 years of age with irritable bowel syndrome with constipation.

FDA Accepts for Priority Review Ipsen’s NDA for Palovarotene

Palovarotene is being reviewed as a therapy for an ultra-rare disease that transforms the body’s soft tissue into bone. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of Dec. 29, 2022.

New FDA Proposal Would Make Adding OTC Approval to Prescription Drugs Easier

Sanofi Lowers Insulin Price

FDA Accepts sBLA for Eylea in Diabetic Retinopathy

Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.

FDA Issues Complete Response Letter for UTI Therapy

Spero Therapeutics was seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection. The FDA has requested an additional clinical trial.

Gilead Resubmits NDA of Long-Acting Lenacapavir for HIV

Biogen Terminates Aduhelm Clinical Trial

Biocodex Selects PANTHERx as New Distributor for Diacomit

Diacomit was approved in 2018 for seizures associated with Dravet syndrome, a rare pediatric disorder.

FDA Updates Safety Labels of Buprenorphine Products

FDA Approves Breyanzi for Additional Indication in Large B-Cell Lymphoma

Breyanzi is now available as a second-line treatment for this aggressive blood cancer.

New Generic Approvals

Generics of Viibryd, Tranxane and Timoptic have recently been approved and launched.

FDA Updates Safety Label of Byetta

Byetta is used to control blood sugar in patients with diabetes. A new warning includes the risk of gallstones and gallbladder inflammation.

Survey: Patient Satisfaction is a Barrier to Utilization Management of Drug Plans

Menarini Submits NDA Elacestrant for Advanced Breast Cancer

Elacestrant is oral therapy that targets estrogen receptor 1, a key resistance mechanism in advanced breast cancer.

FDA Approves Drug Combination for Tumor Agnostic Indication

The FDA approved the combination of Tafinlar and Mekinist for solid tumors with a BRAF V600E mutation. This is the first therapy to be approved that is tumor agnostic for patients with this mutation.

COVID-19 had an Impact on Drug Supply

Purdue Launches Opioid Reversal Nalmefene