Page 12 - Usfda

Cipla gets final approval from USFDA for multiple sclerosis drug

Drug major Cipla on Friday said it has received final approval from the US health regulator for Dimethyl Fumarate capsules, indicated for the treatment of relapsing forms of multiple sclerosis. The newly approved product is a generic therapeutic equivalent version of Biogen IDEC Inc's Tecfidera. Cipla has received final approval for its abbreviated new drug application (ANDA) for Dimethyl Fumarate DR (delayed release) capsules in the strengths of 120mg, 240mg and 120mg and 240mg from the United States Food and Drug Administration (USFDA), the company said in a regulatory filing. Quoting IQVIA (IMS Health) data, Cipla said Tecfidera had US sales of approximately USD 3.8 billion for the 12-month period ending July 2020. Shares of Cipla were trading 2.12 per cent higher at Rs 748.35 apiece on the BSE.

Zydus Cadila gets USFDA nod for multiple sclerosis treatment drug

Zydus Cadila said it received approval from the USFDA to market Dimethyl Fumarate delayed release capsules, indicated for the treatment of patients with relapsing forms of multiple sclerosis

Zydus Cadila gets tentative USFDA approval to market anti-cancer drug

Drug firm Zydus Cadila on Thursday said it has received tentative approval from the US health regulator to market anti-cancer drug Palbociclib Capsules

ICMR exploring saliva-based tests to diagnose Covid-19: Harsh Vardhan

Vardhan also said that no significant or drastic mutations had been found in strains of SARS-CoV-2 in India till now

Zydus Cadila gets USFDA nod to market mineral supplement tablets

Zydus Cadila said it has received approval from USFDA to market potassium chloride extended release tablets, a mineral supplement used to treat or prevent low amounts of potassium in the blood

Emergency use authorisation of drugs or vaccines: What, when, how

The US Food and Drug Administration had recently allowed the emergency use of convalescent plasma therapy for Covid treatment, besides existing drugs such as Remdisivir

USFDA's Hahn plans significant work with AstraZeneca in Covid trial inquiry

The top US Food and Drug Administration official confirmed AstraZeneca's US Covid-19 vaccine trial is on hold

Indoco Remedies gets USFDA nod for blood thinning drug Apixaban tablets

Drug firm Indoco Remedies said it has received approval from the US health regulator for blood thinning drug Apixaban tablets

Donald Trump signs new, expanded executive order to lower US drug prices

Donald Trump signed a new executive order on Sunday aimed at lowering drug prices in the United States by linking them to those of other nations and expanding the scope of a July action

Zydus Cadila gets USFDA nod to market its cancer treatment injection

Drug firm Zydus Cadila said it has received final nod from USFDA to market its generic Doxorubicin Hydrochloride Liposome injection, used for treatment of certain types of cancer, in the US

Alembic Pharma arm gets tentative USFDA nod for drug to treat hypertension

Alembic Pharmaceuticals said its subsidiary has received tentative approval from the US health regulator for Treprostinil injection indicated for the treatment of pulmonary arterial hypertension

Biocon set for bigger insulin play, aims to reach one in five diabetics

Biocon Biologics CEO says portfolio to form a substantial part of $1 bn revenue target, to roll out insulin Aspart by next year

Remdesivir prices may rise after Gilead gets full authorisation from USFDA

In August, Gilead filed an application with the US Food and Drug Administration (USFDA) seeking full approval for remdesivir (Veklury)

Lupin launches generic rheumatoid arthritis drug 'Leflunomide' in US market

Drug maker Lupin on Wednesday said it has launched Leflunomide tablets, used to treat rheumatoid arthritis, in the US market. The company has launched the product in 10 mg and 20 mg strengths after receiving the approval from the US Food and Drug Administration (USFDA) earlier, Lupin said in a statement. The product would be manufactured at drug maker's Pithampur (Unit I) facility in Madhya Pradesh, it added. The Mumbai-based company's product is the generic equivalent of Sanofi-Aventis US LLC's Arava tablets and is indicated for the treatment of adults with active rheumatoid arthritis (RA). As per IQVIA MAT June data, Leflunomide tablets had an annual sales of around USD 42 million in the US.

Zydus Cadila gets approval from USFDA for muscle relaxant injection

Drugfirm Zydus Cadila has received final approval from the US health regulator to market Cisatracurium BesylateInjection, a muscle relaxant given before general anaesthesia

Traditional firms take on Covid-19 through innovative firsts in market

"Immunity and antiviral have become the key words but consumers are not gullible and if they see through a company's claims, it loses the game even before it has begun it," said Harish Bijoor

Gold prices fall to Rs 51,454 per 10 gram, silver plunges to Rs 64,594 a kg

In New Delhi, prices of 22-carat gold plunged sharply to Rs 51,250 from Rs 51,700 per 10 gram in the previous trade while price of 24-carat was at Rs 54,870

Growth risks

India needs reforms to enhance productivity

Lupin gets USFDA approval for asthmatic symptoms prevention drug

Drug major Lupin on Tuesday said it has received approval from the US health regulator for its Albuterol Sulfate Inhalation Aerosol, used for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms. The approved product is a generic version of ProAir HFA of Teva Branded Pharmaceutical Products R&D, Inc. In a regulatory filing, Lupin said it has received approval from the United States Food and Drug Administration (USFDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation. Vinita Gupta, CEO, Lupin said: "The approval is timely as Albuterol MDI is a key rescue inhalation product for asthma patients who are at an increased risk of COVID-19-related complications. We look forward to launching the product this quarter and expect a steady ramp-up through the fiscal year. Quoting IQVIA moving annual total June 2020 data, Lupin said the total Albuterol Sulfate Inhalation Aerosol market had US sales of approximately USD 2.9 billion, of which the ...

Why a vaccine that stops coronavirus won't be enough to end the pandemic

A vaccine's ability to forestall a disease is also how vaccine developers typically design - and how regulators typically evaluate - Phase 3 clinical trials for vaccine candidates