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The FDA will not heed a lawmaker’s request to investigate allegations that the new active ingredient in many nasal decongestants is no more effective than a placebo, citing insufficient data to support this claim.
The FDA will not investigate allegations that the new active ingredient in many nasal decongestants is no more effective than a placebo, citing insufficient data to support this claim.
Plan B should not be distributed OTC because the drug is a much stronger version of regular birth control, which requires a prescription, a senator with a background in women’s health says.
The FDA needs to investigate the drug industry’s replacement of the active ingredient in certain widely used nasal decongestants to make sure these products are effective, Rep. Henry Waxman (D-Calif.) said in an Aug. 23 letter to the agency.
The FDA’s approval of Barr Laboratories’ controversial Plan B contraceptive has removed Senate objections to Andrew von
Eschenbach’s nomination to be FDA commissioner but has landed the agency in more legal trouble.
The FDA’s approval of Barr Laboratories’ controversial Plan B contraceptive has removed Senate objections to Andrew von Eschenbach’s nomination to be FDA commissioner but has landed the agency in more legal trouble.
Barr Pharmaceuticals is making a change to its Plan B application that should clear the way for the FDA to approve the contraceptive for OTC use, a Barr spokeswoman said.
An activist group that is suing the FDA over its handling of the controversial contraceptive Plan B is asking to subpoena all White House documents related to the issue after a top agency official allegedly acknowledged that its decision on the drug was made to “appease the administration’s constituents,” according to documents obtained by WDL.
The FDA has failed to convince critics of its Plan B decisionmaking to drop their hold on Andrew von Eschenbach’s nomination to be FDA commissioner, even with the agency’s introduction of a framework to get the drug approved for OTC use.
The FDA is amending the final monograph for OTC nasal decongestant drugs to add phenylephrine bitartrate (PEB), both individually and in combination drug products in an effervescent dosage form, as generally recognized as safe and effective.