22-460 Amendment - accessdata fda 2025

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Major Amendments (Standard): If no preapproval inspection is required, the FDA will act within 8 months. If a preapproval inspection is needed, the timeline extends to 10 months. Priority Major Amendments: For priority amendments with no preapproval inspection, the FDA will act within 6 months.
/tamsulosin, sold under the brand name among others, is a medication produced by GlaxoSmithKline for the treatment of adult male symptomatic benign prostatic hyperplasia (BPH).
pain or tenderness. Change in sex drive or performance. Dizziness. Headache.
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was patented in 1993 by Glaxo Wellcome (later known as GSK after additional mergers) and was approved for medical use in 2001. In the United States and elsewhere, it is available as a generic medication.
has been shown to cause congenital disabilities in male children secondary to its inhibition of DHT. [31] Therefore, is contraindicated during pregnancy. The medication should not be handled by patients who are or who may be pregnant.

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