Ivax Corporation has received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for sertraline tablets in 25,- 50-, and 100-mg dosage strengths. Sertraline HCl is the generic equivalent of Pfizer’s Generic Zoloft. Ivax believes that it has first-to-file status on this drug and that it will be entitled to 180 days [...]
Alpharma, Inc., has announced the U.S. Food and Drug Administration’s (FDA’s) tentative approval of its Abbreviated New Drug Application for generic sertraline HCl 25-, 50-, and 100-mg tablets. These tablets are the AB-rated generic equivalent of Pfizer’s antidepressant Drug Zoloft. In October, the company announced that it would sell its U.S. and International Generics businesses [...]
Ranbaxy Laboratories has received approval to manufacture and market sertraline HCl tablets in base strengths of 25, 50, 100, 150, and 200 mg. The Ranbaxy formulation is bioequiv-alent to, and has the same therapeutic effect as that of, Zoloft generic (Pfizer) tablets in these doses. Sertraline drug is indicated for the treatment of Major Depressive [...]
