USFDA

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced findings from the U.S. Food and Drug Administration’s (FDA) Mini-Sentinel assessment, confirming the positive safety and efficacy profile of XARELTO® (rivaroxaban) established in the phase III ROCKET AF clinical trials, were published in Pharmacoepidemiology & Drug Safety. Building on the mounting real-world evidence studied in more than 200,000 people, these findings are consistent with conclusions from other analyses and again confirm XARELTO®’s safety and effectiveness across a wide range of patients. The FDA Mini-Sentinel report also notes a lower risk of ischemic stroke was associated with the use of XARELTO® compared to warfarin and lasted throughout the more than three-year analysis.

Sandoz, a Novartis division and the global leader in biosimilar medicines, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira®*.

Zydus Pharmaceuticals (USA) Inc., a wholly owned subsidiary of Cadila Healthcare Limited, has received the final approval from the USFDA to market Valacyclovir Tablets USP in strengths of 500 mg and 1 gm.

The U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

Lupin announced that it has received final approval for its Calcipotriene Topical Solution, 0.005% (Scalp Solution) from the United States Food and Drug Administration (FDA) to market a generic version of Dovonex Scalp Solution, 0.005% of Leo Pharmaceutical Products Ltd.

Rhizen  Pharmaceuticals S.A., an nounced  that the U.S. Food and Drug Administration  (FDA) has granted orphan - drug designation for  the active moiety of Tenalisib  (RP6530),  the Company’s  highly selective and orally active  dual PI3K delta/gamma  inhibitor, for treatment of  peripheral T - cell l ymphoma  (PTCL).

Dr. Reddy’s Laboratories Ltd that it has launched Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran® (melphalan hydrochloride) for Injection in the United States market approved by the U.S. Food and Drug Administration (USFDA).

Aclaris Therapeutics, Inc a dermatologist-led biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved ESKATA™ (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses, or SKs. SKs are non-cancerous skin growths that affect more than 83 million American adults and can be an aesthetic skin concern. SKs tend to increase in size and number with age. The condition is more prevalent than acne, psoriasis and rosacea combined.

Mylan N.V.and Biocon Ltd.  announced that the U.S. Food and Drug Administration (FDA) has approved Mylan´s Ogivri^TM (trastuzumab­dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. OgivriTM has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).