Page 4 - Usfda

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.

Google ropes in ex-US FDA leader Bakul Patel as digital health chief

Google's ambitions range from mining big data for algorithms to developing disease-detecting tools to pumping wearables full of health features

USFDA rush after 2-year lull: 20-30% new products may be open to inspection

The last two years saw limited physical inspections due to travel restrictions during the pandemic

TMS Ep170: Ambuja and ACC, Sonam Wangchuk, IPO size, USFDA's Form 483

Why are top Indian companies vying for Ambuja & ACC? Can Sonam Wangchuk's innovation clear Delhi's air? Market volatility to make companies trim their IPO size? What is USFDA's Form 483? Answers here

Alembic gets final USFDA nod for medication to treat bronchoconstriction

Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Arformoterol Tartrate inhalation solution indicated for long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Arformoterol Tartrate inhalation solution is for strength of 15 mcg (base)/2 mL unit-dose vial, the company said in a statement. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Brovana inhalation solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc, it added. Arformoterol Tartrate inhalation solution is indicated for long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, the company said. This ANDA has ...

Sun Pharma's Halol unit gets 10 observations under USFDA's Form 483

Plant's OAI status is unchanged, hinting at status quo; Sun Pharma says will respond to observations within 15 days

Sun Pharma slips over 2% after USFDA issues observations for Halol facility

In the past five days, the stock has fallen over 5 per cent. In comparison, the S&P BSE Sensex declined 3.75 per cent during the same period

Glenmark gets tentative nod from USFDA for generic psoriasis foam

Glenmark Pharmaceuticals on Monday said its US-based arm has received tentative approval from the US health regulator for its generic Calcipotriene and Betamethasone Dipropionate foam used to treat psoriasis. The tentative approval granted to Glenmark Pharmaceuticals Inc, USA (Glenmark) by the US Food & Drug Administration (USFDA) is for Calcipotriene and Betamethasone Dipropionate foam of strength 0.005 per cent/0.064 per cent, the company said in a statement. It is the generic equivalent of Leo Pharma AS' Enstilar foam, it added. Citing IQVIATM sales data for the 12 months ended March 2022, the company said Enstilar foam, 0.005 per cent/0.064 per cent achieved annual sales of approximately USD 115.2 million. Glenmark said its current portfolio consists of 174 products authorised for distribution in the US marketplace and 48 abbreviated new drug applications (ANDAs) are pending approval with the USFDA.