Biocon gets CDSCO nod for generic diabetes medication
The approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise, the company said in a regulatory filing.
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India Today
a day ago
- India Today
UK watchdog warns of pregnancy risks linked to weight-loss drugs
Women are being advised to use effective contraception while on these medications. () UK health authorities recently cautioned against weight-loss drugs during pregnancy Mounjaro may reduce effectiveness of oral contraceptives Serious risks include acute pancreatitis with severe stomach pain Women using popular weight-loss and diabetes injections, also called "skinny jabs" are being warned to take extra care with contraception and pregnancy plans in the UK. Health authorities say these medicines should not be taken if you're pregnant, planning to get pregnant, or breastfeeding. If someone becomes pregnant while on these medicines, they should speak to a doctor immediately and stop using the medicine. This warning comes from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and includes well-known medicines like Ozempic, Mounjaro, Wegovy, Saxenda and Victoza. These drugs are known as GLP-1 receptor agonists, which help reduce hunger and control blood sugar levels by copying a natural hormone released after eating. Some newer medicines like Mounjaro act on a second hormone that also helps with appetite and blood sugar control. While they are approved for treating type 2 diabetes, and in some cases for weight loss, they are not meant for cosmetic or quick weight-loss purposes. The MHRA said Mounjaro may reduce the effectiveness of oral contraceptives such as the pill in people who are overweight, and that women taking the medication should use barrier contraceptives such as condoms, according to a report in The Guardian. The UK watchdog said it had received 26 pregnancy-related reports for Mounjaro. "These are powerful medications meant to treat serious medical conditions. They should not be used casually or bought from unregulated sources like beauty salons or social media," said Dr Alison Cave, Chief Safety Officer at MHRA. Women are being advised to use effective contraception while on these medications and in some cases for up to two months after stopping them. This is because there isn't enough data to confirm if these drugs are safe for the baby during pregnancy. Forms of contraception include: Oral contraceptives (the pill) Non-oral methods like condoms, the coil, or implants However, Mounjaro may reduce the effectiveness of oral contraceptives in people who are overweight. That means women using Mounjaro should also use a non-oral method of contraception, especially in the first four weeks of treatment or after a dose increase. Another rare but serious risk of GLP-1 medicines is acute pancreatitis, which is inflammation of the pancreas. A warning sign of this is severe stomach pain that moves to the back and doesn't go away. Anyone who feels this should get emergency medical help. The MHRA also reminds users: These medicines must be prescribed by a healthcare professional. Do not buy them online or from beauty clinics, it is illegal and dangerous. Talk to your doctor before starting the medicine to understand risks and benefits. Let your doctor know if you're using one of these medicines before any surgery. Report any side effects through the Yellow Card scheme, which collects safety information on medicines in the UK. The watchdog also warned against extracting leftover medicine from used syringes. Dispose of them safely after completing the recommended doses, the statement read. These reminders come amid rising concerns that many people may be misusing these injections without knowing the full risks, especially women who may become pregnant. Staying informed and cautious is key to using these medicines safely. Women using popular weight-loss and diabetes injections, also called "skinny jabs" are being warned to take extra care with contraception and pregnancy plans in the UK. Health authorities say these medicines should not be taken if you're pregnant, planning to get pregnant, or breastfeeding. If someone becomes pregnant while on these medicines, they should speak to a doctor immediately and stop using the medicine. This warning comes from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and includes well-known medicines like Ozempic, Mounjaro, Wegovy, Saxenda and Victoza. These drugs are known as GLP-1 receptor agonists, which help reduce hunger and control blood sugar levels by copying a natural hormone released after eating. Some newer medicines like Mounjaro act on a second hormone that also helps with appetite and blood sugar control. While they are approved for treating type 2 diabetes, and in some cases for weight loss, they are not meant for cosmetic or quick weight-loss purposes. The MHRA said Mounjaro may reduce the effectiveness of oral contraceptives such as the pill in people who are overweight, and that women taking the medication should use barrier contraceptives such as condoms, according to a report in The Guardian. The UK watchdog said it had received 26 pregnancy-related reports for Mounjaro. "These are powerful medications meant to treat serious medical conditions. They should not be used casually or bought from unregulated sources like beauty salons or social media," said Dr Alison Cave, Chief Safety Officer at MHRA. Women are being advised to use effective contraception while on these medications and in some cases for up to two months after stopping them. This is because there isn't enough data to confirm if these drugs are safe for the baby during pregnancy. Forms of contraception include: Oral contraceptives (the pill) Non-oral methods like condoms, the coil, or implants However, Mounjaro may reduce the effectiveness of oral contraceptives in people who are overweight. That means women using Mounjaro should also use a non-oral method of contraception, especially in the first four weeks of treatment or after a dose increase. Another rare but serious risk of GLP-1 medicines is acute pancreatitis, which is inflammation of the pancreas. A warning sign of this is severe stomach pain that moves to the back and doesn't go away. Anyone who feels this should get emergency medical help. The MHRA also reminds users: These medicines must be prescribed by a healthcare professional. Do not buy them online or from beauty clinics, it is illegal and dangerous. Talk to your doctor before starting the medicine to understand risks and benefits. Let your doctor know if you're using one of these medicines before any surgery. Report any side effects through the Yellow Card scheme, which collects safety information on medicines in the UK. The watchdog also warned against extracting leftover medicine from used syringes. Dispose of them safely after completing the recommended doses, the statement read. These reminders come amid rising concerns that many people may be misusing these injections without knowing the full risks, especially women who may become pregnant. Staying informed and cautious is key to using these medicines safely. Join our WhatsApp Channel
Hans India
3 days ago
- Hans India
Biocon gets CDSCO nod for generic diabetes drug
New Delhi: Biocon on Tuesday said it received approval from the government authorities for a generic diabetes medication – Liraglutide drug substance. Itswholly-owned subsidiary Biocon Pharma has received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India (CDSCO). The approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise, the company said in a regulatory filing. "The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes," Biocon CEO and MD Siddharth Mittal said. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further, he added. "We are now gearing up to launch the product expeditiously through our commercialisation partners in India," Mittal stated.
United News of India
4 days ago
- United News of India
Biocon Pharma gets DCGI nod for diabetes drug liraglutide in India
New Delhi, June 3 (UNI) Biocon Pharma Limited, a biopharmaceutical firm, on Tuesday said that drug regulator, Drugs Controller General of India under the CDSCO (Central Drugs Standard Control Organisation) has given nod to its liraglutide drug for Indian market. The approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled type 2 diabetes mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise. Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon, termed the approval for liraglutide, as a step forward in expanding access of this product to patients suffering from diabetes. 'The approval enables us to address a critical need by making this drug available, and aligns with Biocon's mission to provide affordable, lifesaving medications to those who need it the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India.'' Liraglutide is administered as a once-daily injection and was approved by the US FDA in 2019 for the treatment of children who are ten years or older with type 2 diabetes, making it the first non-insulin drug approved to treat type 2 diabetes in children, said the release. According to various reports, India has an estimated 77 million people above 18 years old living with diabetes (type 2) and nearly 25 million with pre-diabetes. It is the second-highest country in the world for diabetes prevalence after China. UNI AJ PRS
