Company News

Alembic Pharmaceuticals Limited announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base).

AbbVie announced that the Phase 3 ADVANCE trial evaluating the investigational medicine atogepant, an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days, compared to placebo, for all doses across the 12-week treatment period.

Subsidiary of Sun Pharma, Taro Pharmaceutical will acquire Canada's Aquinox Pharmaceutical for USD 8.2 million (approx Rs 61.35 crore).

AstraZeneca has been granted Fast Track Designation in the US for the development of Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) or cardiovascular (CV) death in adults following an acute myocardial infarction (MI) or heart attack.

Cipla Limited announced that it has received final approval for its Abbreviated New Drug Application (“ANDA”) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (U.S. FDA) with a Competitive Generic Therapy (“CGT”) designation. Cipla is the “first approved applicant” for such CGT and, is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla’s product. This 180-day CGT exclusivity will not block the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL.

Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led global integrated pharmaceutical company, today announced the launch of a Single Inhaler Triple Therapy AIRZ-FF - a combination of two bronchodilators, Glycopyrronium & Formoterol and the inhalation corticosteroid Fluticasone propionate, for Chronic Obstructive Pulmonary Disease (COPD).

Pharma major Lupin Limited (Lupin) announced the successful close out of the inspection carried out by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory agency of the United Kingdom (UK), at its three manufacturing units in Pithampur (India). The inspection for the three units at Pithampur (Unit I, Unit II and Unit III) was conducted in January 2020.