What is CRL – Complete Response Letter by USFDA?
Complete response letter is issued by USFDA to new drug / abbreviated application holder, if they determines that we will not approve... Read More
Case Study: Vyleesi™ (Bremelanotide Injection) for HSDD in Premenopausal Women
Posted on24 Jun 2019
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U.S. Food and Drug Administration (FDA) has approved Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire... Read More
FDA Approval of sNDA for DEXTENZA for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for DEXTENZA to include the treatment of ocular inflammation... Read More
A triple-combination therapy for COPD – Breztri Aerosphere’s of AstraZeneca received approval in Japan
Posted on21 Jun 2019
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AstraZeneca announced that Breztri Aerosphere (budesonide/ glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve... Read More
Case analysis: 483 observations – Data Integrity issues in Aurobindo Pharma’s finished dosage formulation plant
Posted on17 Jun 2019
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The US Food and Drug Administration has pointed out data integrity lapses at Aurobindo Pharma Limiteds finished dosages plant at Bachupally, Telengana... Read More
USFDA Approves Amgen’s Trastuzumab Biosimilar, Kanjinti
The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was approved for... Read More
Case Study: USFDA approval of Exeltis’s Slynd, an oral contraceptive tablet
Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced that the US Food and Drug Administration (FDA) has... Read More
USFDA accepted triple drug FDC empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes
Posted on06 Jun 2019
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Boehringer Ingelheim and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application... Read More
Case analysis: Can marketing authorization can be revoked?
Yes. Marketing authorization can be revoked and it generally carried out, in case of safety issued observed with the molecule. Here is... Read More
Luye Pharma’s Rykindo NDA Filing Accepted by the US FDA
Rykindo, Luye Pharma’s innovative, independently developed Extended-Release Microspheres formulation for injection, is one step closer to going on the U.S. market. The... Read More