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April 8, 2011 Approval Letter-RotaTeq
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April 5, 2011 Approval Letter
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Pediatric Exclusivity Statistics
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Written Requests Issued
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Revlimid (lenalidomide): Ongoing Safety Review
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FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies
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FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth
Safety AnnouncementAdditional Information for Consumers and CaregiversAdditional Information for Healthcare ProfessionalsData Summary References Safety AnnouncementDrug Safety Communication on Benzocaine Sprays). These products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums. Methemoglobinemia has been reported with all strengths of benzocaine gels and…
FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References Safety AnnouncementPublic Health Advisory warning about methemoglobinemia with the use of benzocaine sprays during medical procedures. Since then, FDA has received 72 new cases of methemoglobinemia, including three resulting in death, associated with the use of benzocaine sprays, bringing the total to 319 cases…
Benzocaine Topical Products: Sprays, Gels and Liquids
[Posted 04/07/2011] AUDIENCE: Family Practice, Pharmacy, Consumers ISSUE: FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and…