USFDA

Pfizer Inc and BioNTech SE announced that the U.S. Food and Drug Administration has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age.

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo  (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or wet age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month.

Dr. Reddys Laboratories Ltd announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of REVLIMID® (lenalidomide) Capsules, from the U.S. Food and Drug Administration (USFDA). With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for Lenalidomide Capsules, 2.5 mg and 20 mg.

Glenmark Pharmaceuticals Ltd has received final approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Phosphate Foam, 1%, the generic version of Evoclin®1 Foam, 1%, of Mylan Pharmaceuticals Inc.

According to IQVIATM sales data for the 12 month period ending July 2021, the Evoclin® Foam, 1%, market2 achieved annual sales of approximately $12.0 million*.

Myovant Sciences and Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis. The FDA set a target action date of May 6, 2022 for this sNDA under the Prescription Drug User Fee Act (PDUFA).

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics, and  vaccines.  The  group  employs  23000  people  worldwide  and  is  dedicated  to  creating  healthier communities globally.

Cara Therapeutics and Vifor Pharma announced that the U.S. Food and Drug Administration has approved KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis . KORSUVA injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system.

CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE)  Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for mitapivat for the treatment of adults with pyruvate kinase (PK) deficiency.