USFDA

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.

Dr. Reddy's Laboratories Ltd. launched Regadenoson Injection in the U.S. market, a generic therapeutic equivalent of Lexiscan (Regadenoson) injection, approved by U.S. Food and Drug Administration (USFDA).

Lexiscan is a registered trademark of Astellas US LLC. It is an A2A adenosine receptor agonist that is a coronary vasodilator that is commonly used in pharmacologic stress testing. It produces hyperemia quickly and maintains it for a duration that is useful for radionuclide myocardial perfusion imaging.

Zydus Life Sciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Sucralfate Tablets USP, 1 gram (USRLD: Carafate Tablets, 1 gram).

Sucralfate is used to treat and prevent ulcers in the intestines by forming a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly. The drug will be manufactured at the group’s topical manufacturing facility at SEZ, Ahmedabad (India).

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FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). Qalsody is an antisense oligonucleotide that targets SOD1 mRNA to reduce the synthesis of SOD1 protein. The approval was based on a reduction in plasma neurofilament light (NfL), a blood-based biomarker of axonal (nerve) injury and neurodegeneration. 

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective. The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the 2 health of people in the United States.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, the generic version of Cleocin®1 Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg, of Pfizer Inc. Glenmark’s Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

Global pharma major Lupin Limited announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval and GMP Inspection of its API manufacturing facility located in Visakhapatnam (Vizag), India. The inspection was conducted from March 6 to March 10, 2023 and concluded with no observations.

Marksans Pharma Limited hereby announces that it has received final approval from US Food & Drugs Administration for its Abbreviated New Drug Application (ANDA) of Famotidine Tablets USP, 10 mg and 20 mg for over-the-counter (OTC) use.

The product is bioequivalent to the reference listed drug (RLD), Pepcid AC® tablets, a registered trademark of Johnson & Johnson Consumer Inc. which has sales of over $ 200 million in the US market.