Regulatory Updates
Sep 10, 2026•1 min read
FDA Lists Discontinued Hydrocortisone Acetate Injection (ANDA085214)
The FDA record shows Watson Labs' injectable Hydrocortisone Acetate (50 mg/mL) has been discontinued under ANDA085214.
Regulatory Updates
Sep 10, 2026•1 min read
MFDS updates safety labeling for triptolide and azathioprine drugs
The Korean MFDS will amend approval labeling for triptolide and azathioprine products, adding severe skin reaction warnings for triptolide and PRES and tremor warnings for azathioprine.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANI PHARMS' Fosinopril/HCTZ Tablets (ANDA 076608)
The FDA approved labeling submissions for ANI PHARMS' fosinopril sodium and hydrochlorothiazide oral tablets under ANDA 076608.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Multiple Submissions for Lidocaine Hydrochloride Injection (Discontinued Product)
The FDA has approved several labeling and manufacturing submissions for the discontinued injectable lidocaine hydrochloride (2%) product.
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Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Mylan Nisoldipine Extended‑Release Tablets (ANDA 079051) – Discontinued Products
The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Fluoxetine Oral Solution (ANDA077849) by Lannett Company
The FDA has approved ANDA077849 for a fluoxetine oral solution (20 mg/5 mL) manufactured by Lannett Company, adding a new prescription product to the market.
Regulatory Updates
Sep 9, 2026•1 min read
Korea MFDS Expands GIFT Review to Include Patient Experience Data
The Korean MFDS revised its GIFT fast‑track guidelines, permitting patient‑reported symptoms, quality‑of‑life data, preferences, interviews, videos and written opinions as reference material for priority review of rare disease drugs.
Regulatory Updates
Sep 9, 2026•1 min read
MFDS revises GIFT review guidelines to include patient experience for rare disease drugs
South Korea's MFDS updated its GIFT fast‑track review criteria on March 28, adding patient real‑world experience to priority assessment for innovative rare‑disease therapies.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA 079054 for Alfuzosin Hydrochloride Extended‑Release Tablet
FDA granted labeling approvals for Torrent Pharm's discontinued Alfuzosin Hydrochloride 10 mg extended‑release tablet (ANDA 079054).
Regulatory Updates
Sep 9, 2026•1 min read
South Korea adds 15 facilities to police probe over illegal fee refunds
South Korea's Health Ministry has referred 15 additional hospitals and clinics to police over suspected illegal medical fee refunds, bringing the total under investigation to 33.
Regulatory Updates
Sep 9, 2026•1 min read
MFDS adds domperidone contraindication for chromaffin‑cell tumor patients across 38 products
South Korea’s MFDS will revise labeling of 38 domperidone products to contraindicate use in patients with chromaffin‑cell tumors due to risk of severe hypertension.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA084731 for Theophylline Oral Capsules (Discontinued)
The FDA has approved ANDA084731 for Theophylline capsules in 100 mg, 200 mg and 250 mg strengths. All three products are listed as discontinued by sponsor Scherer RP.