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  • The US subsidiary of Dr. Reddy’s Laboratories Ltd. announced that it has reached a settlement with the US Government, in a case that is more than six years old, involving packaging for five blister-packed prescription products. In a joint filing by the parties, Dr. Reddy’s and the US Department of Justice agreed to the settlement of the action without any adjudication of any issue of fact or law.

  • 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.

  • Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.

  • Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for HAILEYTM 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.

  • Celgene Corporation recently announced results from two phase 3 trials evaluating the efficacy and safety of the drug ozanimod. Ozanimod was invented by scientists at The Scripps Research Institute (TSRI). Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, and was compared to the first-line treatment, Avonex® (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS). The findings from the two pivotal phase 3 (SUNBEAM and RADIANCE Part B) trials pave the way for ozanimod to enter the New Drug Approval process with the U.S. Food and Drug Administration (FDA).

  • Takeda Pharmaceutical Company Limitedannounced that data from an 18-month interim analysis of the ongoing Phase 2 DEN-204 trial of its live, attenuated tetravalent dengue vaccine candidate, TAK-003 (also referred to as TDV), have been published in The Lancet Infectious Diseases. The results of this interim analysis, a pre-planned evaluation of data from an ongoing trial, show that TAK-003 is associated with a reduction in the incidence of dengue in children and adolescents. These data were also presented at the American Society of Tropical Medicine and Hygiene Annual Meeting. Phase 3 data are required to confirm these findings.

  • 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.

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