Market Overview

Mylan Pharma Wins Final FDA Approval for ANDA for Phenytoin Chewable Tablets, 50 mg

Share:
Related MYL
Mylan Expands Hepatitis C Licensing Agreement with Gilead to Include Investigational Pan-Genotypic Agent
Cramer Weighs In On Transocean LTD, Mylan Inc And Honda Motor Co Ltd
Mylan Faces Short-Term News Flow And Reputational Risk (Seeking Alpha)
Related PFE
Is The Dollar Really As Strong As Companies Are Suggesting?
Was It Foreseeable For Pfizer To Lower Its 2015 Guidance?
Seeking Alpha's Biotech Weekly: Intercept Pops, Provenge's Prince Valeant, And More (Seeking Alpha)

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phenytoin Chewable Tablets USP, 50 mg. This product is the generic version of Pfizer's Dilantin® Chewable Tablets, which are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments.

Posted-In: News FDA

 

Related Articles (MYL + PFE)

Around the Web, We're Loving...

Get Benzinga's Newsletters