Actualizaciones regulatorias

Biogen and Eisai secured FDA approval for a subcutaneous injection formulation of Leqembi, enabling patients to start and maintain treatment without IV infusion.

The FDA has approved ANDA083004 for STILBESTROL, an oral tablet containing 0.5 mg diethylstilbestrol, marketed by Tablicaps and listed as discontinued.

Germany's Bundestag approved a law to stabilize statutory health insurance premiums, expanding high‑income contributors' burden while capping spending on providers and medicines, drawing attention from Korea.

The FDA approved ANDA 080036 for MK Labs' SOSOL oral tablet containing 500 mg sulfisoxazole. The product is listed as discontinued.

FDA has approved ANDA078641 for a prescription injectable famotidine 10 mg/mL product marketed by Mylan Institutional LLC.

FDA has approved application ANDA078052 for fosphenytoin sodium injection, a prescription product by Fresenius Kabi USA for IM and IV use.

The FDA has granted a tentative approval for Cipla Limited’s ABACAVIR SULFATE oral solution (20 mg) under ANDA 078348.

The FDA has approved several labeling submissions for generic oral Simvastatin tablets (5‑80 mg) under ANDA 077752, confirming their prescription status.

The FDA has granted approval for Fresenius Kabi USA’s preservative‑free OCTREOTIDE acetate injectable products under ANDA 077457, covering three dosage strengths for injection.

FDA records show two Woodward Milrinone Lactate injectable products are listed as discontinued under ANDA077151.

The FDA has approved ANDA084712 for Bethanechol Chloride 10 mg tablets, marketed by Lannett, now listed as discontinued.

South Korea’s MFDS imposed a fine on Green Cross after the company missed the deadline for a post‑marketing efficacy study required under the vaccine’s risk management plan.