Azelastine HCl Nasal Solution, 0.15%
Perrigo Company Plc and Impax Laboratories, Inc
Astepro Nasal Spray (Meda Pharmaceuticals, Inc)
Perrigo Company plc has announced that it has received FDA approval of its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal solution, 0.15%. The ANDA involved contributions from Perrigo and Impax Laboratories, Inc, which will share certain costs and benefits of this product. It is indicated for the relief of symptoms of seasonal and perennial allergic rhinitis in patients 12 years and older.
Nasal spray: 0.15%
For More Information: www.perrigo.com
Activella Tablets (Novo Nordisk Femcare)
Teva Pharmaceuticals has announced the introduction and availability of Mimvey Lo, an AB-rated bioequivalent to Novo Nordisk’s Activella Tablets. The tablets contain estradiol 0.5 mg and norethindrone acetate 0.1 mg. They are indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as the prevention of postmenopausal osteoporosis, in women who have a uterus. When prescribed solely for postmenopausal osteoporosis, therapy should only be considered for women at significant risk, and nonestrogen medications should be considered.
Tablets: 0.5 mg/0.1 mg
For More Information: www.tevagenerics.com
Ohm Laboratories, Inc
Ohm Laboratories, Inc, a wholly owned subsidiary of Ranbaxy Laboratories, Limited, announced today that Ohm has received FDA approval to manufacture and market Valsartan 40-, 80-, 160-, and 320-mg tablets on an exclusive basis. Valsartan is the generic version of Novartis’ Diovan. It is indicated for the treatment of high blood pressure and heart failure.
Tablets: 40, 80, 160, and 320 mg
For More Information: www.ranbaxy.com
Cyclophosphamide tablets (Roxane Laboratories)
As of June 2014, Roxane Laboratories began providing cyclophosphamide in capsules, an FDAapproved, clinically equivalent version of its discontinued cyclophosphamide tablets. The tablets are indicated for the treatment of malignant lymphomas including Hodgkin’s disease and lymphocytic lymphoma, and minimal change nephrotic syndrome in pediatric patients who fail to respond to adrenocorticosteroid therapy. The new capsules are not automatically substitutable for tablets, so pharmacists should verify that scripts specify capsules in addition to the dosage.
Capsules: 25 and 50 mg
For More Information: www.roxane.com