Oakrum Pharma and ANI Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for a generic Cystadane, according to PR Newswire.
The companies said the FDA also granted Competitive Generic Therapy (CGT) of 180 days of exclusivity. Shipments of the generic Cystadane began in early February 2022.
Oakrum founder and CEO Marco Polizzi said, “This is the third generic orphan drug that we have launched since starting this business, and we remain committed to bringing rare disease patients affordable options of pharmaceutical products that currently have few or no generic options.”
“Oakrum currently has licensing rights to seven additional ANDAs filed with the FDA and expects to file additional generic orphan drugs later this year,” he added.
ANI Pharmaceuticals CEO Nikhil Lalwani said, “Our collaboration with Oakrum furthers ANI’s mission of bringing high-quality prescription pharmaceutical products to patients in need. Rare diseases are often overlooked, and we are especially pleased to continue identifying patient populations that are underserved and medicines that can help them.”
“This approval with Competitive Generic Therapy status and resulting 180 days of exclusivity marks another milestone for ANI’s R&D engine as a leader in bringing limited competition products to market,” he added.
Oakrum is a Missouri-based privately-owned biopharmaceutical company that focuses on the development and commercialization of affordable drug therapies.
Minnesota-based ANI Pharmaceuticals is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products.
Cystadane (betaine anhydrous for oral solution) Powder is used to treat high levels of a certain important body chemical (homocysteine) due to an inherited disorder (homocystinuria), according to WebMD.
In homocystinuria, the amino acid homocysteine cannot be broken down, eventually accumulating in the body. This condition causes a wide range of symptoms, such as impaired vision, weak bones, and circulatory issues.
Cystadane contains betaine, a natural substance extracted from sugar beet. In homocystinuria, betaine reduces homocysteine levels by transforming homocysteine into the amino acid methionine, improving the symptoms of the disease.
