Alvogen and Lotus Pharmaceutical Co., Ltd., Receives FDA Final Approval for Buprenorphine/Naloxone Film 2Mg/0.5Mg, 4Mg/1Mg, 8Mg/2Mg and 12Mg/3Mg
January 25, 2019 at 02:01 pm
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Alvogen and Lotus Pharmaceutical Co., Ltd., received FDA final approval for Buprenorphine/Naloxone film 2mg/0.5mg, 4mg/1mg, 8mg/2mg and 12mg/3mg. On January 24, 2019, Lotus and its partner Alvogen received final FDA approval of its application for Buprenorphine Naloxone Sublingual Film, generic of Suboxone Sublingual Film. Buprenorphine/Naloxone film is indicated for the treatment of Opioid Use Disorder (OUD). Lotus and Alvogen is temporarily prohibited from selling its generic product at this time. However, the company expects it will be able to launch in the near future bringing this very important drug to patients in critical need of a generic alternative.
Lotus Pharmaceutical Co Ltd is a Taiwan-based company mainly engaged in the manufacture and sale of generic drugs. The products are mainly solid preparations such as tablets and capsules. The main products include oral anti-cancer drugs, cardiovascular disease drugs, central nervous system drugs, women's health products, osteoporosis drugs and mental disease drugs. The Company is also engaged in the drug research, development and clinical testing business, as well as the product licensing business. The Company mainly distributes products in Taiwan, South Korea, the United States, China mainland, Japan, Europe and Southeast Asia markets.