USFDA

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).

The U.S. Food and Drug Administration approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for HAILEY^TM Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/20 mcg and Ferrous Fumarate Tablets), the generic version of Loestrin®1 Fe 1/20 Tablets, of Allergan Pharmaceuticals International Limited.

Biocon Ltd, Asia's premier biopharmaceuticals company, has launched KRABEVATM, a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, in India.

Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel ® (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).

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Cipla Ltd, a global pharmaceutical company which uses cutting-edge technology and innovation to meet the everyday needs of all patients, announced that its subsidiary, InvaGen Pharmaceuticals Inc. (collectively Cipla), has received final approval for its Abbreviated New Drug Application (ANDA) for Sevelamer Carbonate Tablets, 800 mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Genzyme’s Renvela® Tablets, 800 mg.

Roche announced that the US Food and Drug Administration (FDA) has approved Zelboraf® (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare, serious blood disease characterized by the abnormal multiplication of certain white blood cells called histiocytes, which can invade normal tissues and organs in the body.

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