Formulary Watch |

Exela Pharma Expands Recall of Sodium Bicarbonate

Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.

FDA Accepts sBLA for Evkeeza for Children with Rare High Cholesterol

If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.

Genentech Withdraws Tecentriq Indication for Bladder Cancer

Aldeyra Submits NDA for the Novel Dry Eye Therapy Reproxalap

If approved, reproxalap would be the first inhibitor of RASP, which contributes to ocular inflammation and changes in tear lipid composition.

FDA Grants Priority Review for Duchenne Muscular Dystrophy Gene Therapy

If approved, SRP-9001 (delandistrogene moxeparvovec) would be the first gene therapy for Duchenne. The FDA action date is May 29, 2023.

FDA Issues CRL for Poziotinib for Lung Cancer

An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.

Inflation Reduction Act and the Impact on Pharmaceutical Pricing and Investment Decisions

Provention Bio Chooses Amber as Specialty Pharmacy for Tzield

Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It is administered by intravenous infusion once daily for 14 consecutive days.

FDA Grants Priority Review of BLA for Dengue Vaccine

An FDA decision on Takeda’s dengue vaccine TAK-003 is expected within six months.

Authorities Seize Fake Drugs with Lethal Doses of Meth and Fentanyl

Updated: FDA Approves $3.5 million Gene Therapy Hemgenix for Hemophilia B

FDA Warns About Prolia in Patients with Kidney Disease

An FDA review has found that Prolia can result in low calcium levels in the blood in patients with advanced kidney disease and can lead to hospitalization and death.

GSK Pulls Blenrep from U.S. Market

A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.

Compounding Pharmacies to Help Alleviate Amoxicillin Shortage

FDA Accepts for Priority Review BLA for Epcoritamab

If approved, epcoritamab would be the first bispecific antibody to treat adult patients with relapsed/refractory large B-cell lymphoma. The Prescription Drug User Fee Act date is May 21, 2023.

FDA Updates Target Date for Pegcetacoplan

Appellis had submitted updated data for the pegcetacoplan in age-related macular degeneration, which is considered a major amendment to the NDA. The new PDUFA date is Feb. 26, 2023.

FDA Approves Alternate Dosing Schedule for Rylaze

Rylaze’s dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.

FDA Approves Second Interchangeable Lantus Biosimilar

Lilly’s Rezvoglar is a long-acting human insulin analog. It follows Semglee as a biosimilar that can be substituted for Lantus for both adults and children with diabetes.

FDA Approves First Drug that Delays Diabetes

OptumRx to Cover Amgen’s Biosimilar of Humira

Express Scripts Adds Zoryve to National Formulary

Launched in August, Zoryve is a once-daily, steroid-free cream and is the first topical PDE4 inhibitor approved to treat plaque psoriasis in patients 12 years of age or older.

FDA Advisory Committee Supports Xphozah in CKD

Generic Drug Roundup

Sun Pharma will market SPARC’s phenobarbital, which is under FDA review to treat neonatal seizures. In addition, several new generics have been approved, including a generic of Novartis’ Gilenya for multiple sclerosis and AbbVie’s Lupron for prostate cancer.

FDA Proposes Prescription-to-OTC Naloxone

GSK Limits Use of Zejula for Some Cancer Patients

OptumRx Makes Utilization Management Changes for 2023

FDA Grants Accelerated Approval of Novel Ovarian Cancer Therapy

Elahere is a first-in-class antibody-drug conjugate targeted against folate receptor alpha, a protein on the surface of ovarian cancer cells.

Omnipod 5 Charging Ports are Subject to Overheating

This is second issue related to Omnipod. Last week, the company announced that it had received 50 complaints related to the batteries of Omnipod DASH Personal Diabetes Manager.

FDA Approves Liletta IUD to Prevent Pregnancy for 8 Years

The approval extends the use of Liletta for an additional two years. It is the only hormonal IUD approved for continuous use up to eight years.

FDA Accepts NDA for Generalized Myasthenia Gravis Therapy

Zilucoplan is a targeted therapy that inhibits key components in the underlying disease pathology. The anticipated PDUFA date is in the fourth quarter of 2023.