Novadoz gets FDA green light for generic Rapaflo
Novadoz Pharmaceuticals has received the Food and Drug Administration’s clearance to market silodosin in 4-mg and 8-mg capsules.
The product is the generic of Allergan’s Rapaflo.
Silodosin is indicated for the symptomatic relief in men experiencing the condition benign prostatic hyperplasia.
The product is available in 4-mg 30 count bottles, and 8-mg 30 and 90 count bottles.
“Novadoz’s introduction of silodosin is the first of many DAY 1 generic launches for the organization. With our robust pipeline of high volume and niche generics, and our vertical integration of API, Product Formulation, and Finished Dosage Manufacturing, we look forward to building customer relationships based on that value proposition,” Novadoz president North America generics, Seshu Akula said.
Sandoz, Gan & Lee ink deal to develop insulin biosimilars
Sandoz, a Novartis division, has entered into an agreement with Gan & Lee to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes.
The commercialization and supply agreement with Gan & Lee aims at bringing to market biosimilar versions of glargine, lispro and aspart — the three top insulin medicines by sales.
Gan & Lee is a leading insulin supplier headquartered in China with more than 20 years’ experience in insulins and production capacity with attractive cost of goods sold structures.
Under the terms of the agreement, Sandoz will be fully responsible for commercializing these medicines in the EU, United States, Switzerland, Japan, South Korea, Canada, Australia and New Zealand.
Gan & Lee will be responsible for manufacturing and development, with support from Sandoz, and shall adhere to the stringent manufacturing requirements established for Sandoz biosimilars. Other specific terms of the agreement are confidential.
“Across the world, people suffering from diabetes still face very real access challenges. In fact, U.S. patients have reported taking less insulin than recommended by their doctor because they couldn’t afford it — putting them at higher risk for serious complications,” Sandoz CEO, Richard Francis, said.”At Sandoz, we have significant experience disrupting and transforming marketplaces, and look forward to extending access for the more than 420 million people worldwide suffering from diabetes.”
Hikma launches generic Ampyra
Hikma Pharmaceuticals has launched dalfampridine extended-release tablets in a 10-mg dosage strength.
The product, which is the generic of Acorda Therapeutics’ Ampyra, is indicated to help improve walking in adult patients with multiple sclerosis as demonstrated by an increase in walking speed.
Ampyra had a market value of roughly $543 million in 2017, Hikma said.
“We are very pleased to be launching dalfampridine extended-release tablets, a life-enhancing medicine for people with multiple sclerosis. This product highlights our ability to successfully litigate patent-protected Paragraph IV products, improving patient access to high-quality, affordable medicines,” Hikma generics division, president Brian Hoffman, said.