Page 17 - Usfda

Aurobindo Pharma's Andhra unit gets Form 483 with 3 USFDA observations

Aurobindo Pharma on Tuesday said the US health regulator has issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The Pydibhimavaram unit was classified as OAI (official action indicated) on May 17, 2019, and subsequently given a warning letter on June 20, 2019 by the USFDA, Aurobindo Pharma said in a regulatory filing. Subsequently, the company said it has responded to the warning letter and carried out the committed corrections and the USFDA authorities inspected the facility from July 25 to August 2, 2022. "At the end of the inspection, we have been issued a Form 483 with three observations and none of these observations are related ..

Cipla Q1 net dips 4% to Rs 686 cr, revenue down 2% on tapering Covid sales

Domestic revenue dips 8.4% as Covid-19 share of branded prescription business normalises; North American business up 10% to $155 million

Alembic Pharma receive USFDA approval to market drug for skin treatment

Alembic Pharmaceuticals on Friday said its subsidiary has received approval from the US health regulator to market medication for treating actinic keratoses

Glenmark Pharma arm gets final USFDA nod for birth control capsules

Glenmark Pharmaceuticals Ltd on Friday said its US arm has received final approval from the US health regulator for its generic Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate birth control capsules. The approval granted by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc is for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules of strength 1 mg/20 mcg, the company said in a statement. It is the generic version of Taytulla capsules of Allergan Pharmaceuticals International Ltd, it added. Citing IQVIA sales data for the 12 months ended May 2022, the company said the Taytulla Capsules market achieved annual sales of approximately USD 85.9 million.

Lupin gets USFDA approval for generic blood pressure lowering drug

Drug firm Lupin on Monday said it has received an approval from the US Health regulator to market generic medication to treat high blood pressure.

Zydus gets USFDA approval to market generic antifungal medication

Zydus Lifesciences on Monday said its subsidiary has received approval from the US health regulator to market antifungal Efinaconazole Topical solution

Dr Reddy's gains over 3% on new drug launch in the US market

The company launched its generic version of fesoterodine fumarate extended-release tablets that can be used for treating overactive bladder in the US market.

Aurobindo Pharma receives Sebi's warning letter over ongoing USFDA audit

The letter is in regards to certain disclosures made by the company on the ongoing USFDA audit of company's Unit-1 and observations made by the USFDA between the period 2019 to 2022

US FDA authorizes Covid-19 vaccines for kids as young as 6 months

The US Food and Drug Administration (FDA) has authorized emergency use of the Moderna and Pfizer-BioNTech Covid-19 vaccines for children as young as 6 months, the first for kids in this age group

USFDA authorises first coronavirus shots for infants, preschoolers

The Food and Drug Administration's action follows its advisory panel's unanimous recommendation for the shots from Moderna and Pfizer

US FDA advisers approve Moderna, Pfizer vaccines for kids under 5

COVID-19 shots for US infants, toddlers and preschoolers moved a step closer Wednesday

Alembic Pharma gets USFDA nod for cancer treatment drug in US market

Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancers, in the American market

India's Serum Institute to make Novavax's Covid vaccine for US market

The company has indicated in the first quarter earnings call that it has reached a major milestone in its pathway to an emergency use authorisation from the US Food and Drugs Administration

Lupin receives tentative approval from USFDA to market Ivacaftor tablets

The product is the generic equivalent of Vertex Pharmaceuticals' Kalydeco tablets, Lupin said in a statement

Ahmedabad-based Zydus gets USFDA approval to market generic acne drug

A combination of Adapalene (a retinoid) and Benzoyl Peroxide (an antibiotic and skin-peeling agent), the gel is used to decrease the number and severity of acne pimples

Novavax's Covid vax effective, but concerns over sideeffects remain: FDA

Vaccine NVX-CoV2373 is already being locally manufactured by the company's India partner, the Pune-based Serum Institute of India (SII) under the brand name Covovax

Covid-19 vaccine: SII to test Novavax for Omicron variant strain

The Pune-based company has also got a nod from the Indian drug regulator's office to manufacture trial batches of this vaccine for the purpose of testing, sources indicated.

Specialty business set to spur growth for Sun Pharma in next 3 yrs: Experts

Global specialty drug sales for Sun Pharma have grown by 39% YoY in FY22 to $674 million

Alembic Pharma gets USFDA approval to market Pirfenidone tablets

Alembic Pharmaceuticals said it has received approval from the US health regulator to market Pirfenidone tablets used to treat lung disease in the American market.

Aurobindo hits 2-year low; dips 11% in a week on USFDA's 6 observations

Analysts at ICICI Securities expect Aurobindo Pharma's adjusted PAT to de-grow 30.4 per cent year-on-year (YoY) to Rs 557.90 crore in the March 2022 quarter.