Alembic receives FDA final approval for Betamethasone Valerate Foam, 0.12%

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg

This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India

Granules India receives ANDA approval for Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile

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.

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

Granules India receives ANDA approval for Trazodone Tablets

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

Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP

Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity

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

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