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Questions and Answers About FDA's Enforcement Action Against Unapproved Pilocarpine Hydrochloride Ophthalmic Solutions

What action is FDA taking regardingPilocarpine Hydrochloride Ophthalmic Solution? 

The Food and Drug Administration (FDA) has sent Warning Letters to the manufacturers of unapproved Pilocarpine Hydrochloride Ophthalmic Solution, used to control intraocular pressure (Table 1). Alcon, Inc. has obtained FDA approval for the reduction of elevated intraocular pressure (Table 2).

 
Why is FDA taking this action?
 
FDA is taking this action as part of its continuing effort to ensure that drugs marketed in the United States have the required FDA approval, which means that they have been found to be safe, effective, of good quality, and appropriately labeled. 
 
What does this mean for the companies that received the Warning Letters?
 
Manufacturers of unapproved Pilocarpine Hydrochloride Ophthalmic Solution have 90 days after the date of their Warning Letters to stop manufacturing unapproved new drugs.  Firms distributing unapproved Pilocarpine Hydrochloride Ophthalmic Solution have 180 days to stop distributing unless they have other violations. If firms continue manufacture or distribution of these drugs after these grace periods, FDA may proceed immediately to enforcement action including, but not limited to, seizure and injunction.
In addition, unapproved drugs that are introduced onto the market after September 19, 2011 are subject to immediate enforcement action without prior notice and without regard to the priorities listed in the Marketed Unapproved Drugs Compliance Policy Guide. See
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf 
  
What effect will FDA’s action have on the use ofPilocarpine Hydrochloride Ophthalmic Solution?  Are there alternatives?
 
Practitioners and consumers will continue to have access to FDA-approved Pilocarpine Hydrochloride Ophthalmic Solution.  The approved firm has communicated with FDA that it is able to meet the total market demand.
 
How can people tell the difference between FDA-approved and unapproved products?
 
People cannot tell the difference between FDA-approved and unapproved drugs by looking at drug labels. A National Drug Code (NDC) number on the drug label or otherwise assigned to the drug does NOT indicate approval.
 
FDA databases will show whether a drug is FDA-approved. Drugs@FDA contains most FDA-approved drugs. The National Drug Code (NDC) Directory includes a column marked “Application Number.” FDA-approved drugs will have an associated new drug application (NDA) or abbreviated new drug application (ANDA) number in this column.
 
Table 1.  List of Unapproved Pilocarpine Hydrochloride Ophthalmic Solution Subject to Warning Letters

Drug Name
Firm
NDC#
Pilocarpine Hydrochloride Ophthalmic Solution 1%
Bausch & Lomb, Inc.
24208-0676
Pilocarpine Hydrochloride Ophthalmic Solution 2%
Bausch & Lomb, Inc.
24208-0681
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Bausch & Lomb, Inc.
24208-0686
Pilocarpine Hydrochloride Ophthalmic Solution 0.5%
Bausch & Lomb, Inc.
24208-0806
Pilocarpine Hydrochloride Ophthalmic Solution 6%
Bausch & Lomb, Inc.
Labeling does not list NDC
 
 
 
Pilocarpine Hydrochloride Ophthalmic Solution 1%
Akorn, Inc.
17478-0223
Pilocarpine Hydrochloride Ophthalmic Solution 2%
Akorn, Inc.
17478-0224
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Akorn, Inc.
17478-0226

 
Table 2.  List of FDA-Approved Pilocarpine Hydrochloride Ophthalmic Solution

Drug Name 
Firm
NDC #
NDA#
Pilocarpine Hydrochloride Ophthalmic Solution 1%
Alcon, Inc.
00998-0203
N200890
Pilocarpine Hydrochloride Ophthalmic Solution 2%
Alcon, Inc.
00998-0204
N200890
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Alcon, Inc.
00998-0206
N200890