For UNVC--11THREE LLC to legally launch a generic prescription 5% Lidocaine patch, the company must complete a complex multi-year regulatory process: Abbreviated New Drug Application (ANDA) Submission & Review (1.5 to 3 Years): Formulate a bioequivalent patch.
Conduct human bioequivalence studies. Submit an ANDA to the FDA. The average FDA review and approval process takes 10 to 30 months under standard GDUFA review cycles. Manufacturing & cGMP Compliance (6 to 12 Months): Secure a cGMP-certified pharmaceutical manufacturing plant. Clear FDA pre-approval facility inspections. FDA Drug Listing & Active NDC (1 to 2 Months): Obtain an official Labeler Code. Submit Structured Product Labeling (SPL) to activate the product's NDC in the FDA database. An FDA submission is never a guaranteed approval,
Fully launching a legal, billable 5% Lidocaine Rx patch takes years of formal clinical and regulatory execution—not a few weeks or months. A 5% Lidocaine patch is a prescription-only (Rx Only) drug-it cannot be sold or billed under over the counter (OTC) wellness rules.
11Three-LLC CEO-Pat Kelly and Univec Inc CEO- David Dalton is looking at possible repercussions for falsely claiming such mis-leading information
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