Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 57
Drug Approval
Drug Approval | 23 November 2021

Boehringer Ingelheim gets CDSCO nod for Jardiance

Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease

Drug Approval
Drug Approval | 23 November 2021

U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution

The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies

Drug Approval
Drug Approval | 23 November 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)

Drug Approval
Drug Approval | 22 November 2021

European Commission approves Roche’s Gavreto

Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC

Drug Approval
Drug Approval | 22 November 2021

Amneal gets approval for Difluprednate ophthalmic emulsion

The company is moving towards complex and more differentiated products

Drug Approval
Drug Approval | 20 November 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years

Drug Approval
Drug Approval | 20 November 2021

U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism

Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth

Drug Approval
Drug Approval | 19 November 2021

Natco launches Tipanat tablets in India

It is used for the treatment of advanced colorectal and gastric cancer

Drug Approval
Drug Approval | 18 November 2021

Zydus Cadila receives U.S.FDA approval for leukaemia injection

Nelarabine is in a class of medications called antimetabolites

Drug Approval
Drug Approval | 17 November 2021

Alembic JV receives final approval for Mupirocin cream

The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA

Drug Approval
Drug Approval | 17 November 2021

U.S FDA authorises EaseVRx, immersive virtual reality for pain relief

EaseVRx employs the principles of cognitive behavioural therapy and other behavioural therapy techniques for the reduction of pain and pain interference

Drug Approval
Drug Approval | 15 November 2021

Zydus Cadila receives tentative approval for IBS tablets

The group now has 324 approvals and has so far filed over 400 ANDAs

Drug Approval
Drug Approval | 15 November 2021

European Commission approves Celltrion’s Covid-19 medicine

The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week

Drug Approval
Drug Approval | 13 November 2021

European Commission approves Ronapreve to treat Covid-19

Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus

Drug Approval
Drug Approval | 12 November 2021

Sun Pharma to introduce molnupiravir in India

The Drug Controller General of India (DCGI), is reviewing clinical data of molnupiravir for the treatment of Covid-19 in adults in India

Drug Approval
Drug Approval | 10 November 2021

Zydus Cadila receives approval for glycopyrrolate injection

Glycopyrrolate injection can also be used in adults as an adjunctive therapy for the treatment of gastrointestinal ulcer when a rapid effect is desired or when oral medication is not tolerated

Drug Approval
Drug Approval | 08 November 2021

Lupin launches fenofibrate in the US

The drug helps in managing cholesterol

Drug Approval
Drug Approval | 01 November 2021

Dr. Reddy's launches Ephedrine Sulfate injection in the US

The Akovaz brand and generic market had U.S. sales of approximately US $ 67.5 million MAT for the most recent twelve months ending in August 2021

Drug Approval
Drug Approval | 01 November 2021

Sun Pharma's Winlevi available in the US

It is the first U.S. FDA approved novel topical mechanism for acne in nearly 40 years

Drug Approval
Drug Approval | 29 October 2021

Boehringer Ingelheim announces EMA marketing authorisation for spesolimab

Generalized pustular psoriasis is characterized by episodes of widespread eruptions of painful, sterile pustules

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