USFDA

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.

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorization for the Moderna COVID-19 vaccine (mRNA-1273) to include a third dose for immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

The U.S. Food and Drug Administration approved a new indication for Xywav for idiopathic hypersomnia in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night's sleep. Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.