Mylan Laboratories Inc announced that the US Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Metoprolol Tartrate and Hydrochlorothiazide Tablets, 50/25 mg, 100/25 mg, and 100/50 mg strengths. Metoprolol Tartrate and Hydrochlorothiazide Tablets are the generic version of Novartis' Lopressor HCT Tablets.
Mylan also announced that the FDA has granted tentative ANDA approval for Mylan Pharmaceuticals' Cetirizine Hydrochloride Tablets, 5 mg and 10 mg, and Sertraline Hydrochloride Tablets, 25 mg (base), 50 mg (base) and 100 mg (base). Cetirizine Hydrochloride and Sertraline Hydrochloride are the generic versions of Pfizer's Zyrtec and Zoloft, respectively.
Mylan Laboratories Inc is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc, Mylan Technologies Inc, UDL Laboratories Inc and Mylan Bertek Pharmaceuticals Inc that develop, manufacture and market an extensive line of generic and proprietary products.