Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers

USFDA completes inspection of Lupin's Dabhasa facility with no observations

The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations

Dr. Reddy's launches drug-free migraine management device Nerivio in Europe

NATCO Pharma receives warning letter from USFDA for facility in Kothur, Telangana

The company will respond to the Warning Letter within the stipulated timelines

Lupin launches first generic version of Oracea in US

Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients

Shivalik Rasayan’s API facility gets 7 observations from USFDA

These observations are procedural in nature and will be responded within the stipulated time

Eugia Steriles gets 3 observations from USFDA for injectable facility

The observations are procedural in nature and will be responded to within the stipulated time

Gland Pharma receives USFDA approval for Eribulin Mesylate Injection

The Product is expected to be the first generic approval on the market

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483

Zydus receives tentative approval from USFDA for Letermovir Tablets

Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)