Case Study: Pfizer’s Lyrica’s patent extension with paediatric exclusivity
USFDA granted 6-month pediatric exclusivity to Lyrica, which helps to Lyrica to extent the patent expiration by additional 6 month. Lyrica received... Read More
What is pediatric exclusivity?
Posted on29 Nov 2018
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Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and may run concurrently with a patent but... Read More
Case Study: USFDA Pediatric Disease Designation for Imara’s lead Product Candidate IMR-687 for Sickle Cell Disease
Posted on15 May 2017
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Imara Inc., a biotechnology company dedicated to developing novel therapeutics for patients with sickle cell disease (SCD) and other hemoglobinopathies, announced today... Read More
Eisai got Approval for Antiepileptic Drug Banzel (rufinamide) As Adjunctive Treatment For Pediatric Patients
Posted on17 Feb 2015
Tagsadditional indication approval, approval of an additional pediatric indication, Eisai got Approval for Antiepileptic Drug Banzel (rufinamide) As Adjunctive Treatment For Pediatric Patients, Indication approval for, Lennox-Gastaut Syndrome, Rufinamide, Rufinamide is a triazole derivative
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Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has received approval of an additional pediatric indication for Eisai’s antiepileptic... Read More