Medscape

First-Time Generic Approvals: Metaglip, Zofran ODT, Floxin Otic

Editor's Note: According to the FDA Web site, on Nov. 29, 2005, the FDA's Center for Drug Evaluation and Research (CDER) rescinded the Nov. 18, 2005, approval of Kali Laboratories' ANDA 76-506 for ...
Medscape

First-Time Generic Approvals: Phenergan Tablets, Floxin Otic, Sodium Bicarbonate Injection

Jan. 4, 2006 — The US Food and Drug Administration (FDA) approved in November 2005 first-time generic formulations of promethazine HCl 12.5-, 25-, and 50-mg tablets for approved indications in ...
Drug Store News

FDA approves Hi-Tech's generic Floxin

WASHINGTON The Food and Drug Administration has granted approval to Hi-Tech Pharmacal for its application for ofloxacin otic solution, 0.3 percent. The drug, which is a generic version of Daiichi ...
Reuters

Antibiotics can harm tendons, FDA warns

WASHINGTON (Reuters) - Certain antibiotic drugs such as Bayer AG's Cipro need stronger "black box" warnings about the risk of tendonitis and ruptured tendons, U.S. health regulators said on Tuesday.
Business Line

Caplin Point Labs’ subsidiary gets USFDA approval for Ofloxacin Otic Solution 0.3%

https://www.thehindubusinessline.com/markets/caplin-point-labs-subsidiary-gets-usfda-approval-for-ofloxacin-otic-solution-03/article67718608.ece Copy Caplin Point ...