Cipro Generics Approved; Dr. Reddy's Gets Exclusivity On 100 Mg Strength
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA approves 14 ANDAs for the Bayer antibiotic in the 250 mg, 500 mg and 750 mg tablet strengths. Dr. Reddy's is the only ANDA filer to receive approval for the 100 mg dose.
You may also be interested in...
Depomed’s Proquin XR Ciprofloxacin Formulation Clears FDA
Proquin XR’s more gradual release of dosage leads to a more advantageous adverse event profile than other ciprofloxacin products, Depomed says. The company is seeking a marketing partner and expects to launch its extended-release ciprofloxacin by year-end.
Natrecor Use Should Be Limited, Independent Panel Convened By J&J Says
The cardiologist panel calls for use of the congestive heart failure therapy to be "strictly limited" to patients that present with symptoms in the hospital setting. The expert panel also recommends that Scios "immediately undertake" a professional educational campaign about Natrecor's appropriate uses.