ANVISA completes inspection at Caplin Steriles' facility at Gummidipoondi

Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.

Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer

Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone

Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals

Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer

Third approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu in less than two years

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations

Zydus receives final approval from USFDA for Valbenazine Capsules

Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)

Granules India receives ANDA approval for Trazodone Tablets

Trazodone tablets are indicated for the treatment of major depressive disorder in adults

Atul Bioscience received EIR from USFDA for Ambernath facility

The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept

Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia

Shilpa Pharma Lifesciences received CEP from EDQM for ursodeoxycholic acid

Ursodeoxycholic acid or ursodiol is a naturally occurring bile acid that is used dissolve cholesterol gall stones

Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries

Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause

The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo

Zydus receives approval from COFEPRIS to market? Mamitra to treat various cancers

The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance

Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe

USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations