MSN/Novadoz intros 4 generics
MSN Labs, under the Novadoz label, has received the Food and Drug Administration’s blessing for albendazole, droxidopa, deferasirox, and pregabalin.
Novadoz has commenced shipping of all the products which received approvals during Q1 2021.
Albendazole, which is the generic of Albenza, is available in a dosage strength of 200 mg and is marketed in bottles of 2 tablets. It is indicated for the treatment of neurocysticercosis which is an infection caused by the pork tapeworm in the muscles, brain, and eyes that may cause seizures, brain swelling, and vision problems. The brand and generics had a market value of $26.9 million, for the most recent 12 months, the company said.
Droxidopa, which is the generic of Northera, is available in 100 mg, 200 mg, and 300 mg dosage strengths and comes in bottles of 30 capsules. It is indicated for the symptomatic treatment of dizziness, lightheadedness, or fainting/black out sensation due to neurogenic orthostatic hypotension (a sudden fall in blood pressure). Novadoz participated in a Day 1 launch of the product, coinciding with the expiration of the brand exclusivity. Previous 12 month published sales for the brand totaled $366 million.
Deferasirox granules, the generic of Jadenu Sprinkles, is available in dosage strengths of 180 mg, and 360 mg and come in a carton of 30 sachets. The product is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It also is used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions.
Pregabalin ER, the generic of Lyrica CR, is available in dosage strengths of 82.5 mg, 165 mg, and 330 mg and comes in bottles of 30. The product is indicated for the treatment of pain caused by nerve damage due to diabetes or shingles (herpes zoster).
"The first quarter of 2021 was a very active period for the MSN/Novadoz organization with four FDA approvals. We successfully introduced these products to the market, while keeping pace with the high demand for our existing product line created by the pandemic," said Seshu Akula, Novadoz president North America Generics. "MSN's position as a global leader in APIs has provided Novadoz with the scale and leveraged strength comparable to some of the largest generic pharma companies in the United States. We are well positioned in the generic industry with a deep pipeline of oral solids, injectable, and specialty products that we expect to launch over the next 10 years."