USFDA

​With inflation reduction act, Medicare finally having the power to negotiate prescription drug prices with pharmaceutical industries which will affect millions of Americans across all 50 states and the District of Columbia

It will lead to prescription drug costs capped at USD 2,000 annually in Medicare, and will save hundreds of dollars per year on health insurance premiums because of the law.

Pfizer Inc. and BioNTech announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals ages 12 years and older.

And on the same day,  Moderna, Inc. has also received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Omicron-targeting bivalent COVID-19 booster vaccine.

The U.S. Food and Drug Administration has approved Xenpozyme for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency in adult and pediatric patients.

Xenpozyme is the first therapy indicated specifically for the treatment of ASMD (acid sphingomyelinase deficiency), and is currently the only approved treatment for this disease.

U.S. Food and Drug Administration (USFDA) issues Form 483s to three sites of Biocon Biologics at India and Malaysia. USFDA issues 11 observations each for the two sites in Bengaluru and 6 observations for the Malaysia site.

USFDA conducted three on-site inspections of Biocon Biologics seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia. These inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022.

Axsome Therapeutics, Inc a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITYTM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults.

Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world. In India, The Company has strong skills in product development, process chemistry and manufacturing complex API as well as dosage forms.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Prochlorperazine Maleate tablets, USP 5 mg and 10 mg.

Prochlorperazine tablets are used to treat nervous, emotional, and mental conditions (eg. schizophrenia) and non-psychotic anxiety. It is also used to control severe nausea and vomiting. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

The U.S. Food and Drug Administration prioritizes the health and safety of American consumers and patients as well as animals and uses a variety of tools for the appropriate oversight of FDA-regulated products and establishments. With manufacturers and supply chains dispersed around the world, the FDA works to help ensure that only products that meet our rigorous standards reach the U.S. marketplace.

Natco Pharma Limitedannounces that the U.S. Food and Drug Administration has granted approval to its partner Breckenridge Pharmaceutical Inc’s Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit) for the 60mg/1.5mL (40mg/mL) strength.