FDA Approves ANDA210245 for Pomalidomide Oral Capsules

The U.S. Food and Drug Administration (FDA) announced approval of application ANDA210245 for pomalidomide oral capsules. The submission, made by sponsor MSN, includes three product variants: 2 mg, 3 mg, and 4 mg capsule strengths. All products are designated as prescription‑only and are not reference drugs. The original submission (submission number 1) received standard review priority and achieved approved status (AP) on September 2, 2026. The approval letter is available through the FDA’s docket. Key details: - Route: Oral - Dosage form: Capsule - Strengths: 2 mg, 3 mg, 4 mg - Marketing status: Prescription - Sponsor: MSN - Application number: ANDA210245 - Submission status: Approved (AP) as of 2026‑09‑02 - Reference drug: No - Reference standard: No The FDA’s approval allows MSN to market generic pomalidomide capsules in the United States.