The FDA had a busy week.
The US Food and Drug Administration (FDA) has been busy this week under newly appointed commissioner Scott Gottlieb. The agency approved a handful of new drugs, doses and treatments, and even threatened to revoke the approval of a prescription painkiller in an unprecedented move.
Want to stay up to date on all the latest approvals that affect you? Here are the latest FDA moves you need to know about.
June 8 — For the first time, the FDA requested that a pharmaceutical company remove an opioid painkiller from the market because its risks outweigh its benefits. People have been abusing Endo Pharmaceuticals’ oxymorphone hydrochloride (Opana ER) nasally since its approval, but since a reformulation in 2012 rendered the drug more susceptible to intravenous abuse. That led to a serious outbreak of HIV and Hepatitis C, the FDA said in a statement.
June 9 — Truvada has been used as a pre-exposure prophylaxis (PrEP) drug since 2012. Now, the FDA has approved two generics from Teva Pharmaceuticals that it says are bioequivalent and therapeutically equivalent to the name brand drug, which can be used to help at-risk patients reduce the risk of contracting HIV-1 in combination with safe sex practices.
June 9 — AbbVie Pharmaceuticals’ ritonavir (Norvir), an HIV drug, was approved for treatment of pediatric patients. The new form of ritonavir comes in <100 mg dose increments and does not contain alcohol or propylene glycole, making it safer for pediatric patients, according to the agency.
June 8 — Orencia – a subcutaneous drug for patients with moderate to severe active polyarticular juvenile idiopathic arthritis, has had its approval expanded to include patients ages 2 and up. Manufactured by Bristol-Myers Squibb, the drug was previously only approved for children ages 6 and up.
June 6 — Alkermes’ Pharmaceuticals received FDA approval for a new 2-month dosage for aripiprazole lauroxil (Aristada), an extended-release injectable suspension for the treatment of schizophrenia. The newest approval means the drug will be available in four total doses, increasing options for patients and physicians alike.
June 5 — The Sapien 3 Transcatheter Heart Valve was approved for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater, according to the FDA. The approval marks a milestone improvement in care, because previous treatments required open heart surgery, which increases the risk of complications in many patients.
June 5 — The FDA granted regulatory clearance to Claret Medical for Sentinel, a cerebral protection system used during transcatheter aortic-valve replacement (TAVR). Sentinel cut strokes by 63% in the 72 hours following TAVR, a reduction that lasted up to 90 days.
June 2 — The FDA approved nonacog beta pegol (Rebinyn), a treatment for on-demand treatment and control of bleeding episodes and the perioperative management of bleeding in hemophilia B patients