Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – July 2024

USA

FDA Approves First Orally Disintegrating Birth Control Tablet

The FDA has approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating contraceptive tablet for pregnancy prevention. While the active ingredients have been approved since 1968 in swallowable form, Femlyv provides an alternative option for individuals who have difficulty swallowing medications.

Draft Guidance Issued on Pediatric Inflammatory Bowel Disease Drug Development

The FDA has released draft guidance titled “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment,” offering recommendations for clinical development programs targeting pediatric ulcerative colitis and Crohn’s disease. The guidance addresses study population selection, trial design, efficacy endpoints, and safety considerations.

FDA Approves First Generic Methimazole for Hyperthyroidism in Cats

The FDA has approved Felanorm, the first generic methimazole product for feline hyperthyroidism. The agency confirmed that Felanorm contains the same active ingredient as Felimazole Coated Tablets and includes no inactive ingredients that affect bioavailability.

EUROPE

EMA Issues Updated Safety Advice for Mysimba Use with Opioids

The EMA has strengthened recommendations to manage risks associated with the weight loss medicine Mysimba when used alongside opioid-containing products. Because naltrexone in Mysimba blocks opioid effects, opioid pain medications may not work effectively. Patients requiring opioid therapy, including prior to surgery, should stop Mysimba at least three days beforehand.

EMA Recommends Non-Renewal of Authorization for Translarna

The EMA’s CHMP has advised against renewing the conditional authorization for Translarna (ataluren), indicated for Duchenne muscular dystrophy caused by nonsense mutations in patients who are still able to walk.

AUSTRALIA

Safety Concerns Surround Compounded Colic Preparations Containing Atropa belladonna

The TGA has received reports of serious adverse events in infants and children linked to compounded colic and wind preparations containing Atropa belladonna. Investigations are underway to determine necessary regulatory actions.

Robust Extreme Capsules Found to Contain Undeclared Prescription-Only Analogue

Testing has identified the presence of o-propyl vardenafil, an analogue of the erectile dysfunction drug vardenafil, in Robust Extreme capsules. The undeclared substance poses significant health risks, particularly when combined with other medications.

CHINA

Progress in Rare Disease Initiatives Offers New Hope

China’s ongoing efforts to support individuals with rare diseases—highlighted through the story of a patient living with osteogenesis imperfecta—continue to advance public awareness and access to care.

China Unveils Healthcare Reform Priorities for 2024

A newly issued list of healthcare reform measures focuses on strengthening public health services, improving public hospital operations, and enhancing medicine-related systems. These priorities were discussed at a recent national conference on healthcare development and reform.

MALAYSIA

NPRA Analyzes GMP Deficiencies in On-Site Inspections

Malaysia’s NPRA has released findings from its analysis of deficiencies identified during GMP inspections of local and foreign manufacturers. GMP inspections cover pharmaceutical products, biologics including cell and gene therapy products, traditional and herbal products, health supplements, and cosmetics.