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Business Standard
23-05-2025
- Business
- Business Standard
Alembic Pharma receives USFDA approval for generic hypertension drug
Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Time of India
23-05-2025
- Business
- Time of India
Alembic Pharma gets USFDA nod for generic high blood pressure treatment drug
Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA.
Metro
15-05-2025
- Health
- Metro
Urgent recall of soups, rice and porridge over 'life-threatening' risk in US
More than a dozen varieties of soup, rice and porridge mixes have been recalled in the US for containing three undeclared allergens. NatureMills US Inc is recalling 17 of its items sold nationwide because they contain wheat, milk and sesame, which were not listed in the labels. The company based in Prosper, Texas, announced on Tuesday that 'people who have an allergy or severe sensitivity to these allergens run the risk of serious or life-threatening allergic reactions if they consume these products'. NatureMills rice mixes under the recall include the Idly Chilli Powder, Sesame Rice Mix, Dal Garlic Rice Mix, Moringa Rice Mix, Curry Leaf Rice Mix, Vallarai Rice Mix and Horsegram Rice Mix. Its affected soups are the Wonderberry Leaf Soup, Moringa Leaf Soup, Avarampoo Soup and Horsegram Soup. Spice mixes and powders that are recalled include the Traditional Sambar Powder and the Traditional Rasam Powder. The company's Black Kavuni Porridge Mix, as well as its Garlic Vadam, Tomato Vadam and Rice Papad, are also recalled. More Trending NatureMills issued the recall after a routine audit found that the three ingredients were missing from the labels. 'The issue was the result of a oversight in the packaging process,' stated the notice from the US Food & Drug Administration (FDA), which is responsible for protecting public health across the nation. 'Immediate corrective measures have been implemented.' Consumers with allergies to the ingredients are advised to throw away the products and contact NatureMills for a replacement or full refund. Get in touch with our news team by emailing us at webnews@ For more stories like this, check our news page. MORE: History of Air Force One as Trump eyes accepting $400,000,000 Qatari plane MORE: Brain dead woman Adriana Smith forced to be kept alive due to draconian US law MORE: Trump's health secretary says people shouldn't take 'medical advice from me'
Business Upturn
15-05-2025
- Business
- Business Upturn
Alembic Pharma gets USFDA nod for Rivaroxaban tablets across four strengths; to launch 2.5 mg in Q1 FY26
By Aditya Bhagchandani Published on May 15, 2025, 13:42 IST Alembic Pharmaceuticals Limited announced on May 15 that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths. These tablets are therapeutically equivalent to Xarelto, a product marketed by Janssen Pharmaceuticals, Inc., and are used to reduce the risk of major cardiovascular and thrombotic vascular events in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). The company plans to launch the 2.5 mg strength in the first quarter of FY26. According to IQVIA, the estimated market size for the 2.5 mg dosage in the U.S. is $445 million for the 12 months ending March 2025, while the market size for the 10 mg, 15 mg, and 20 mg strengths collectively stands at $8,052 million. With this approval, Alembic now holds a cumulative total of 222 ANDA approvals, which includes 198 final approvals and 24 tentative approvals from the USFDA. Alembic Pharmaceuticals, headquartered in Vadodara, India, is a vertically integrated pharmaceutical company engaged in manufacturing and marketing of generic drugs globally. The company has over 5,200 field personnel and a well-established brand presence in the Indian generics market. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Metro
07-05-2025
- Health
- Metro
Urgent recall of 4,500 cases of canned beans over 'life-threatening' risk
Thousands of cases of canned beans have been recalled in 23 US states over an undeclared allergen that could pose a life-threatening health risk. Vietti Food Group has recalled 4,515 cases of its 15-ounce Yellowstone Brown Sugar Molasses Baked Beans because they did not state they contain soy. 'Individuals with an allergy or severe sensitivity to soy risk serious or life-threatening allergic reactions if they consume this product,' stated the company's announcement published by the US Food & Drug Administration (FDA) on Monday. The affected products have the Best If Used By date of February 17, 2028, printed at the bottom of each can. The label is dark gray with the item name printed in white over a burgundy strip, and has a picture of a bowl of beans. More Trending Retailers distributed the cans to the states of Arizona, Colorado, Delaware, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Missouri, New Hampshire, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah and Virginia. There have been no reports of illness related to consuming the beans from customers, according to the company based in Nashvillle, Tennessee. Consumers are advised to return the product for a full refund, and contact Vietti Food Group with any questions. A individual with a soy allergy can have their immune system overreact to soy proteins and experience symptoms including stomach problems, itching and coughing, according to the Cleveland Clinic. Get in touch with our news team by emailing us at webnews@ For more stories like this, check our news page. MORE: Urgent search for missing girl after sister found 'starving and locked in closet by mum' MORE: Trump is not stopping at Gulf of America as he 'plans to rename the Persian Gulf' MORE: Major travel requirement change you need to fly across US comes into effect today
