Page 17 - Usfda

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.

Alembic arm receives final USFDA approval for generic fever blisters drug

Alembic Pharmaceuticals on Wednesday said its wholly-owned arm Aleor Dermaceuticals has received final approval from the US health regulator for its generic Docosanol cream indicated for cold sore/fever blisters on the face or lips. The final approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Docosanol cream, 10 per cent (over the counter), the company said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product Abreva Cream, 10 per cent (OTC) of GlaxoSmithKline Consumer Healthcare, it added. Citing IQVIA data, Alembic said Docosanol cream, 10 per cent (OTC) has an estimated market size of USD 60 million for 12 months ending December 2021. Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from the USFDA, it added.

Aurobindo, Sun Pharma, Jubilant recall products in US market: USFDA

Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons

Alembic gets USFDA nod to market lvabradine used in treating heart failure

Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market lvabradine tablets, used to treat heart failure, in the American market. The company has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for lvabradine tablets (5 mg and 7.5 mg), Alembic Pharmaceuticals said in a regulatory filing. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). lvabradine Tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure. lvabradine Tablets are also indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. According to IQVIA, ...

Lupin receives USFDA approval for anti-depressant drug

It is the generic equivalent of Pristiq, extended-release tablets, 25 mg of PF PRISM C.V, it added

Lupin's New Jersey facility gets 13 US FDA observations

The observations do not, however, imply any restriction on supplies

FDA authorises second booster of Pfizer/BioNTech, Moderna Covid shots

FDA authorises another booster dose of the Pfizer or Moderna Covid vaccine for people age 50 and up

Alembic Pharma targets 10-12 product filings from Karkhadi facility

Resolution of the observations made by the USFDA (for which Alembic has already responded to the regulator) is critical for Alembic's US business

Unichem Laboratories gets USFDA approval for generic Nebivolol tablets

Unichem Laboratories on Wednesday said it has received approval from the US health regulator to market its generic version of Nebivolol tablets indicated for the treatment of hypertension