ViiV Healthcare, a GlaxoSmithKline company, communicated to the FDA that several HIV medications they manufacture will be discontinued by the end of 2023. Epzicom® (abacavir sulfate, lamivudine) 600/300mg tablets and Trizivir® (abacavir sulfate, lamivudine, zidovudine) 300mg/150mg/300mg tablets will be discontinued...
Eli Lilly, one of three insulin manufacturers in the country, announced plans to reduce list prices of insulin by 70%. Humalog 100 units/mL will be reduced in price starting in Q4 of 2023. The price of nonbranded Insulin Lispro Injection...
The FDA issued a Federal Register notice that assessed the safety and effectiveness of certain naloxone hydrochloride products for nonprescription use, hoping to make the opioid overdose reversal agent more accessible to the public. The preliminary assessment is intended to...
The FDA approved Tzield® (teplizumab-mzwv) injection, a new drug that can delay the onset of type 1 diabetes by several months or years. Type 1 diabetes occurs when the immune system attacks and destroys the cells that make insulin, requiring...
Golden State Medical Supply, Incorporated initiated a voluntary recall of Clopidogrel 75mg Tablets (lot# GS046745) and Atenolol 25mg Tablets (lot #GS046745) due to a label mix-up. Atenolol is indicated for the treatment of hypertension, to lower blood pressure, while Clopidogrel...
Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg – fixed combination tablets indicated to lower blood pressure and treat hypertension – due to presence of Nitrosamine Drug...
Vi-Jon, LLC has issued a nationwide voluntary recall for all lots of magnesium citrate saline laxative oral solution lemon flavor, 10 FL Oz (296 mL) due to microbial testing that identified the presence of gluconacetobacter liquefaciens. This microbe can be...
The FDA granted Emergency Use Authorization (EUA) to the Novavax COVID-19, Adjuvanted vaccine for individuals aged 18 and older. This vaccine is administered in two primary doses given three weeks apart. The vaccine was assessed in an ongoing randomized, blinded,...
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 in favor of recommending an Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine for individuals aged 18 and older. Phase 3 clinical trials with 30,000 people saw an...
Bryant Ranch Prepack Inc. is voluntarily recalling one lot of morphine sulfate 30 mg Extended-Release tablets and one lot of morphine sulfate 60 mg Extended-Release tablets, as the labels for these two products were mixed-up. Morphine sulfate is an opioid...
The FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. These products are marketed as treatments...
The FDA has limited the authorized use of the Johnson & Johnson/Janssen COVID-19 Vaccine to individuals for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals who elect to receive the Johnson &...
Sandoz Inc. issued a recall of 13 lots of Orphenadrine Citrate 100 mg Extended Release (ER) tablets to the consumer level due to the presence of a nitrosamine impurity. Orphenadrine is used as an adjunct to rest, physical therapy, and...
The FDA authorized a second booster dose of either the Pfizer or Moderna COVID-19 vaccines for individuals aged 50 and older at least four months after their first booster dose, and for immunocompromised individuals at least four months after their...
The CDC announced proposed draft updates to the Clinical Practice Guideline for Prescribing Opioids. This draft notice is available to the public and can be commented on until April 11, 2022. The CDC’s opioid guidelines have shaped opioid prescribing policies...
