Us Drug Approvals

Granules India gets US regulator FDA's approval for generic ADHD drug

Drug firm Granules India on Tuesday said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder. Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, the drug firm said in a statement. The approved drug is available in multiple strengths; 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, it added. The company's product is the generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, the company said. The medication is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults. Lisdexamfetamine dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasising ..

USFDA still struggling to conduct pending drug inspections after Covid

Federal regulators responsible for the safety of the US drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the US and across the world, The Associated Press has found. An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections since before the pandemic. The firms that are overdue for safety and quality inspections represent about 42 per cent of the 4,700 plants that are currently registered to produce drugs for the US and previously underwent FDA review before May 2019, the AP found. Most of the overdue plants are in the US, but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost US prescriptions. Generic drugmakers are under intense pressure to cut their costs and some will do that by cutting quality, sa

Zydus Lifesciences hits all time high on USFDA nod for drug worth $2 Bn

Zydus Lifesciences stock surged as much as 2.61 per cent, hitting its all time high at Rs 1,313.05 per share on the BSE in Friday's intraday deals

Sun Pharma receives US FDA approval for drug to treat alopecia areata

Autoimmune disorder characterised by hair loss affects some 700,000 people in the US

Zydus Lifesciences hits all time high on USFDA nod for multiple drugs

Shares of Zydus Lifesciences zoomed up to 1.93 per cent, hitting its all time high at Rs 1203.20 per share on the BSE in Thursday's intraday trade

AstraZeneca chemotherapy gets US nod for certain type of endometrial cancer

Endometrial cancer ranks as the fourth most prevalent cancer among women in the US. In 2022, it affected more than 66,000 patients

Biocon Biologics announces getting US FDA approval for eye treatment drug

Company says approval is a 'significant milestone' and marks entry in new therapeutic area in the US

Safer eyedrops may require new FDA powers in US amid recalls & infections

When you buy eyedrops at a US store, you might assume you're getting a product made in a clean, well-maintained factory that's passed muster with health regulators. But repeated recalls involving over-the-counter drops are drawing new attention to just how little US officials know about the conditions at some manufacturing plants on the other side of the world and the limited tools they have to intervene when there's a problem. The Food and Drug Administration is asking Congress for new powers, including the ability to mandate drug recalls and require eyedrop makers to undergo inspections before shipping products to the US. But experts say those capabilities will do little without more staff and resources for foreign inspections, which were a challenge even before the COVID-19 pandemic forced regulators to skip thousands of visits. The FDA is not getting its job done in terms of drug quality assurance inspections abroad, said David Ridley of Duke University and co-author of a recen

Zydus Lifesciences gets six observations from USFDA for API plant

Zydus Lifesciences on Friday said the US health regulator has issued six observations after inspecting its active pharmaceutical ingredient (API) site in Ahmedabad, Gujarat. The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing. There were no data integrity related observations, it added. Besides, there are no repeat observations from the previous inspection, it noted. There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said. The company will closely work with the USFDA to address the observations, it added.

Granules India gets USFDA nod for generic pantoprazole sodium tablets

Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic pantoprazole sodium delayed-release tablets used in the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets of strengths 20 mg and 40 mg, Granules India said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug, Protonix Delayed-Release Tablets, 20 mg and 40 mg strengths, of Wyeth Pharmaceuticals LLC, it added. Pantoprazole sodium delayed-release tablets are indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD) -- a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus. The medicine is also used for the maintenance ..

World's most expensive drug approved to treat hemophilia at $3.5 mn a dose

CSL Behring's Hemgenix, administered just once, cut the number of bleeding events expected over the course of a year by 54%, a key study of the therapy found

Lupin gets US drug regulator's nod for generic oral contraceptive pill

Drug maker Lupin on Friday said it has received approval from the US health regulator to market Drospirenone tablets, used to prevent pregnancy, in the American market. The company has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Drospirenone Tablets in 4 mg strength, the Mumbai-based drug maker said in a statement. The company's product is the generic equivalent of Exeltis USA Inc's Slynd tablets, it added. As per IQVIA MAT September 2022 data, Drospirenone tablets had estimated annual sales of USD 141 million in the US market.

Lupin launches generic Duexis tablets in US to treat rheumatoid arthritis

Drug firm Lupin on Wednesday said it has launched generic Duexis tablets used to treat the symptoms of rheumatoid arthritis and osteoarthritis in the US market.

USFDA's drug approvals for Indian firms halved in H1CY21: Report

ANDAs granted have halved in H12021, compared to pre-pandemic levels

US officials authorize emergency use of antibody-drug Actemra from Roche

US health officials have granted emergency use for another antibody-drug to help hospitalised patients with the most dangerous cases of Covid-19.

Cost, timeline: Facts about Pfizer-BioNTech's '90% effective' Covid vaccine

The companies said the vaccine was more than 90% effective and they have so far found no serious safety concerns, priming it for possible speedy regulatory approvals

FDA new drug approval run rate down in FY20 for most Indian pharma majors

According to analysts, companies are skeptical about entering crowded opportunities

Govt mulls faster drug approval process, regulatory system overhaul

The industry, which has been lobbying for faster approvals for quite some time now, says the current pandemic should help expedite the reforms process

Healthy trend: Indian pharma firms see rise in USFDA drug approvals in FY18

As the 2017-18 financial year enters the final quarter, a look at formulation approvals by the US Food and Drug Administration (FDA) in the year till date (YTD) period shows an improvement over last year. Deepak Malik, associate director at Edelweiss Securities, says 750-800 approvals had come in 2016-17. In 2017-18, around around 1,000 approvals for Abbreviated New Drug Applications (ANDAs) to FDA are likely to get approval. "So far, around 700 or so approvals have come for ANDAs, and the last quarter is expected to see another 300 or so," he said. Of the major companies that sell drugs in that country, Ahmedabad-headquartered Cadila Healthcare (Zydus) has received the largest number of approvals, at 76, so far in FY18. There were only 14 for the company in all of FY17. Aurobindo Pharma had done well in FY17, securing 73 approvals, followed by Actavis at 40. FY17 had seen Sun Pharmaceutical, this country's largest drug major by valuation, launch generic cancer drug Gleevec that had .