Linagliptin

New Delhi: Zydus Lifesciences on Thursday said it has received approval from the US health regulator to market a generic diabetes drug . The company has received tentative approval from the US Food and Drug Administration (USFDA) for Empagliflozin and Linagliptin tablets, a statement said. The tablets in a combination are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Linagliptin is appropriate. The product will be produced at the group's formulation manufacturing facility at SEZ, Ahmedabad, the drug maker said. As per the IQVIA MAT September-2025 data, Empagliflozin and Linagliptin tablets had annual sales of USD 215.8 million in the US.

Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., said that new Inflation Reduction Act-mandated Medicare prices for 15 prescription drugs "stand in stark contrast " to "counterproductive 'deals' we saw before," under the Biden administration. The U.S. has revealed price reductions for the second round of prescription drugs negotiated by the Centers for Medicare & Medicaid Services (CMS) through the Inflation Reduction Act (IRA). Headlining the list of 15 treatments that will undergo price reductions in 2027 are Novo Nordisk’s semaglutide products, Ozempic and Wegovy.The negotiated price for Ozempic is $274 per month compared to the current list price of $959. Meanwhile, the new price for higher doses of Wegovy will be $385 per month, according to a CMS document. The adjusted prices are what Medicare will pay drugmakers for the medicines.Prices for drugs on the list have been slashed by between 38% and 85%, according to CMS. The discounts will cut Medicare’s costs for the 15 drugs by 44% and save taxpayers roughly $12 billion per year from prior spending levels, the agency said.While pushing for lower drug prices through his Most Favored Nation (MFN) plan, President Donald Trump has largely downplayed the IRA as a tool for achieving them. The program was established in 2022 under President Joe Biden. Medicare price reductions go into effect at the start of next year for the initial round of 10 drugs selected for negotiations.“This year’s results stand in stark contrast to last year’s,” said CMS Administrator Mehmet Oz, M.D., in a release. “Using the same process with a bolder direction, we have achieved substantially better outcomes for taxpayers and seniors in the Medicare Part D program—not the modest or even counterproductive ‘deals’ we saw before.”Next year, another round of 15 drugs will be selected for price reductions that will go into effect in 2028. That will be followed by a round of 20 drugs that will see price reductions in 2029.On the list of newly announced price reductions are two drugs from AbbVie. Antipsychotic treatment Vraylar was slashed from a list price of $1,376 per month to $770, while irritable bowel syndrome medicine Lynzess was adjusted from $539 to $136 per month. Also on the list are two drugs: Boehringer Ingelheim. Lung disease drug Ofev will see a reduction from $12,622 to $6,350 per month, while the price of Type 2 diabetes treatment Tradjenta was cut from $488 to $78 per month.GSK has two drugs on the list as well, both to treat COPD and asthma. The price of Breo Ellipta was reduced from $397 to $67 per month, while the monthly price of newer Trelegy Ellipta was cut from $654 to $175.The most expensive drugs on the list are cancer treatments, topped by Bristol Myers Squibb’s multiple myeloma treatment Pomalyst, which will see a monthly price slash from $21,744 to $8.650. Pfizer’s breast cancer drug Ibrance will be cut from $15,741 to $7,871 per month, according to the CMS document.The price for AstraZeneca’s blood cancer drug Calquence has been cut from $14,228 to $8,600, while Pfizer and Astellas have seen the monthly price of their prostate cancer treatment Xtandi reduced from $13,480 to $7,004.Also slashed were prices for Salix’s gastrointestinal treatment Xifaxan, from $2,696 to $1,000 per month; Amgen’s psoriasis drug Otezla, from $4,722 to $1,650; Merck’s Type 2 diabetes treatments Januvia and Janumet, from $526 to $80 per month; and Teva’s movement disorders drug Austedo, which goes from $6,623 to $4,093. As for the price reductions for the highest-profile drugs on the list, Ozempic and Wegovy, a Novo spokesperson said that the company continues “to have serious concerns about the Inflation Reduction Act’s impact on patients” and that it remains “opposed to government price setting.”“We have seen that government price setting has not translated to lower out-of-pocket costs for patients and can lead to a loss of coverage for medications and higher insurance premiums,” the spokesperson said. “We will continue to work with stakeholders and policymakers to expand affordable access to our medicines through both government and commercial insurance plans.​”