FDA warns 7 manufacturers against marketing methylsynephrine as dietary ingredient
SILVER SPRING, Md. – The Food and Drug Administration last week sent out seven warning letters to companies marketing the ingredient methylsynephrine (also called Oxilofrine and p-hydroxyephedrine) as a dietary ingredient. According to the agency, methylsynephrine is not a dietary ingredient as defined by the Federal Food, Drug and Cosmetic Act.
"We request that you take prompt action to correct the violation cited above, as well as any other violations associated with your … product or other products marketed by your firm that list methylsynephrine as a dietary ingredient in the labelingm," the agency stated in each of the letters. "It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations."
FDA threatened to seize any methylsynephrine product still marketed for sale.
The warning letters were welcomed by the Council for Responsible Nutrition, which represents dietary supplmement manufacturers and suppliers.
“We applaud FDA for taking action against companies breaking the law and potentially putting consumers at risk," stated Steve Mister, president and CEO. "Selling products that list methylsynephrine as a dietary ingredient is illegal because the ingredient, also known as oxilofrine, has not been subjected to the New Dietary Ingredient notification process, a requirement under the law," he said. "Responsible marketers and manufacturers of supplements who compose the mainstream dietary supplement industry are in lockstep with FDA when it comes to enforcing the law and protecting the safety of their consumers, and we strongly urge the companies that received these warning letters — and any others that may be selling this illegal ingredient — to heed the agency’s warning immediately."
Consumers should not use products containing methylsynephrine, oxilofrine, or p-hydroxyephedrine, Mister added.
Dr. Reddy’s, CutisPharma announce API supply, joint development partnerships
WILMINGTON, Mass. — Dr. Reddy’s Laboratories and specialty pharmaceutical company CutisPharma announced Tuesday agreements for active pharmaceutical ingredient (API) supply and joint development as a way to advance several of CutisPharma’s research and development programs.
“This partnership has significant strategic benefits for both parties,” CutisPharma CEO Dr. Neal Muni said. “Dr. Reddy's Laboratories’ breadth of expertise and international infrastructure provide great synergy to CutisPharma's own R&D and commercial organizations and will be a significant catalyst in our plans to fast-track the development of three of our programs towards New Drug Application (NDA) filings.”
CutisPharma recently opened a new manufacturing center at its headquarters and the partnership will see the acceleration of three drugs in its pipeline toward approval by the Food and Drug Administration.
“We continuously engage in research to find innovative solutions that address the unmet needs of patients and to create a robust healthcare ecosystem,” Dr. Reddy’s VP and global head of CPS business Deepak Sapra said. “The partnership with CutisPharma will further enhance and strengthen their R&D portfolio in bringing good health to millions in the country.”
Diplomat announces availability of Lilly’s Taltz
BY DSN STAFF
FLINT, Mich. — Diplomat Pharmacy announced Tuesday that it had been selected as part of Eli Lilly and Co.’s limited-distribution network for its recently approved plaque psoriasis treatment Taltz (ixekizumab).
"Psoriasis is a serious chronic disease that can have debilitating symptoms," Diplomat president Gary Kadlec said. “Taltz enables patients an important treatment option.”
Information about Diplomat’s psoriasis program can be found here.
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