Latest Articles in Regulatory
Zydus Gets Final Approvals From USFDA To Market Generic Drugs
Zydus Lifesciences on Tuesday informed that it has received final approval for two drugs from the United States Food and Drug Administration (USFDA) including Doxepin Hydrochloride Capsules and Levothyroxine Sodium for Injection
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Sanofi Gets Marketing Nod From CDSCO To Sell Its Diabetes Drug
Sanofi India on Monday informed that it has received marketing authorization for its diabetes drug Soliqua (in a pre-filled pen) from the Central Drugs Standard Control Organization (CDSCO)
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Indian Immunologicals Gets DCGI Approval For Measles-Rubella Vaccine
Measles is caused by a virus that lives in the nose and throat mucus of an infected person and spreads easily through breathing, coughing, and sneezing. There is no specific antiviral drug available to treat measles
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Glenmark Gets USFDA Nod For First-in-human Study For Tumors, Lymphomas
Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals, the global pharmaceuticals company received acceptance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for GRC 54276 to proceed with a Phase 1/2, first-in-human, clinical study of GR
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DCGI Alerts States, UTs Against Raw Materials From Maya Chemtech, Supplier Of Marion Biotech
The Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi has issued a letter to the states and union territory licensing authorities against the usage of raw materials produced by Delhi based Maya Chemtech India that supplied the ingredients for the drugs at Marion Biotech which caused
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Marksans Pharma Gets USFDA Nod For Famotidine Tablets
The OTC Famotidine Tablets USP, 10 mg and 20 mg, are acid reducers which used to treat conditions where reduction of stomach acid is needed, such as acid indigestion, occasional heartburn, or sour stomach from eating or drinking certain foods or beverages
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Zydus Gets Approval For Generic Anti-viral Cream From FDA
Acyclovir belongs to a class of medications known as antivirals. Acyclovir cream is used to treat cold sores (fever blisters; blisters that are caused by a virus called herpes simplex) on the face or lips. The product will be launched shortly in the US market
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Zydus Gets USFDA Nod For Vigabatrin Oral Solution
Vigabatrin for oral solution is indicated for the treatment of Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older
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Alembic Pharma Announces USFDA Approval For Docetaxel Injection
Docetaxcel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck
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USFDA Clears Sanofi's Bleeding Disease Therapy
Sanofi's replacement therapy - Altuviiio - is entering a market dominated by rivals like Takeda Pharmaceutical, Bayer AG and Novo Nordisk, which sell factor replacement therapies that have been the standard treatment for decades
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