Pharma Major Lupin Limited announced that its US subsidiary, Gavis Pharmaceuticals received a tentative approval from the US FDA for selling Moxifloxacin hydrochloride tablets, a generic version of Bayer Healthcare Pharmaceuticals’ Avelox tablets.
Lupin’s Moxifloxacin hydrochloride tablets are the AB rated generic equivalent of Bayer Healthcare Pharmaceuticals Inc.’s Avelox Tablets and can be substituted by the pharmacist.
Non-AB rate equivalents may not be substituted by the pharmacist without the permission from the doctor as they are considered therapeutic alternatives and not generic substitutes.
Moxifloxacin hydrochloride is an antibacterial prescription medicine approved by the USFDA for the treatment of certain infections, such as acute worsening of chronic bronchitis; pneumonia; and skin, abdominal, and acute sinus infections in adults 18 years of age and older.
Avelox had US sales of $ 30.1 million (IMS MAT June 2016) and is part of the fluoroquinolone family of drugs that have come under increasing scrutiny for their side-effects.
Lupin manufactures a wide range of branded & generic formulations, biotechnology products and APIs globally.
For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs 136,539 million ($ 2.09 billion) and Rs 22,607 million ($ 345 million) respectively.