The U.S. Food and Drug Administration (FDA) approved on Monday an affordable version of the drug lenacapavir, which is used for HIV prevention every two years. This decision brings this breakthrough medicine closer to the markets of low-income countries.
This approval was announced by Dr. Reddy's Laboratories, an Indian manufacturer of the lenacapavir generic, as well as the global health initiative Unitaid.
The U.S. Food and Drug Administration (FDA) has granted approval for the use of the antisense oligonucleotide bepiruvirsen injections. This drug will be used in combination with standard antiviral therapies to combat chronic hepatitis B.
This approval marks the introduction of the first drug of its class intended for the treatment of this infection. Bepiruvirsen is indicated for use in adult patients who do not have liver cirrhosis.
Prescription of the drug requires that patients receive antiviral therapy for at least six months and have a surface antigen level of the virus not exceeding three thousand international units per liter. Information about the approval was posted on the agency's official portal.
More than three hundred people in Uzbekistan have already been tested for HIV using Taxomat devices, which allow for saliva test results to be obtained in approximately 20–40 minutes. It is planned that these devices will be installed in all regions of the country by the end of 2026.
Maftuna Saidova, press secretary of the Committee for Sanitary and Epidemiological Welfare and Public Health, presented this data on October 20 at a briefing held at the Content Production Center for Mass Media.
This initiative aims to expand access to anonymous screening and ensure early detection of HIV infection. The implementation of self-testing programs is stipulated by Presidential Decree No. PP-14 of January 20, 2023. Special attention is paid to making testing accessible to various population groups, including migrant workers.
Taxomat devices are installed in crowded public places, airports, and railway stations. Currently, they are available at the Republican AIDS Center, Tashkent International Airport named after Islam Karimov, as well as in the airports of the regions of Andijan, Namangan, Surkhandarya, Bukhara, Kashkadarya, Navoi, Khorezm, Samarkand, and Fergana. Additionally, the devices operate in the Republic of Karakalpakstan and at the Zaamin sanatorium in the Jizzakh region.
Testing is conducted independently, without the involvement of medical personnel or invasive procedures, and does not require specialized laboratory equipment. This approach may be convenient for people who fear injections or blood tests, as well as for those who need a fast and confidential way to check.
To use the device, a person must scan an identity document, receive a test, and perform the procedure using a saliva sample. Information from the document is integrated into the electronic system and used according to established procedures to provide feedback, medical consultations, and referral for further examination.
It is important to note that a positive result from a self-test is not a final HIV diagnosis. In such cases, people are informed about the need for additional laboratory testing and advised to consult a regional AIDS center. If the diagnosis is confirmed, the patient is immediately included in the free medical monitoring program at the relevant regional center and receives antiretroviral therapy.
With timely treatment, adherence to the prescribed medication regimen, and following medical recommendations, people living with HIV can maintain good health for many years.
Alembic Pharmaceuticals Ltd announced on Monday that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its generic drug, Ciprofloxacin and Dexamethasone Otic Suspension USP.
This medication is intended for the treatment of certain ear infections in children aged six months and older, as well as in adult and elderly patients.
The Abbreviated New Drug Application (ANDA) indicated that it is therapeutically equivalent to the reference listed drug (RLD) Ciprodex Otic Suspension, 0.3 per cent/0.1 per cent, manufactured by Sandoz Inc.
The drug is indicated for the treatment of infections caused by sensitive isolates of specific microorganisms under particular conditions. These include acute otitis media (AOM) in pediatric patients aged 6 months with tympanostomy tubes, as well as acute otitis externa (AOE) in pediatric, adult, and elderly patients.
Citing IQVIA data, the company noted that the estimated market size for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3 per cent/0.1 per cent, is valued at $110 million USD over 12 months ending in June 2026.
With this approval, Alembic has accumulated a total of 246 ANDA approvals from the U.S. health regulator, of which 226 are final and 20 are preliminary.
