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New Delhi, Apr 7 (PTI) Aurobindo Pharma on Tuesday said it has received final approval from the US health regulator for its generic version of dapagliflozin tablets used to control blood sugar levels in people with type 2 diabetes. The final approval granted by the US Food & Drug Administration (USFDA) to manufacture and market dapagliflozin tablets is for strengths 5 mg and 10 mg, Aurobindo Pharma said in a regulatory filing. These are bioequivalent and therapeutically equivalent to the refer ...Read More >
Chennai: The US has imposed 100 per cent duty on the import of patented pharmaceuticals and associated pharmaceutical ingredients. Generic drugs have been kept out of the duty for the time being. But, if pharma companies increasingly seek evergreening of patents, they will see fewer off-patented drugs in the pipeline. "I have determined that it is necessary and appropriate to impose a 100 percent ad valorem duty rate on the import of patented pharmaceuticals and associated pharmaceutical ingred ...Read More >
Mumbai/Naples: Lupin has taken a step forward in expanding its U.S. generics portfolio, securing regulatory progress for a key injectable product used in surgical care. Lupin has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Sugammadex Injection. The approval covers two dosage strengths -- 200 mg/2 mL and 500 mg/5 mL -- both in single-dose vial formats. The company's product has been deemed bioequivalent to Merck's Bridion i ...Read More >
Ahmedabad -- Senores Pharmaceuticals Limited today announced that it has entered into a definitive agreement to acquire 100% equity stake in Apnar Pharma Private Limited ("Apnar Pharma"), along with the acquisition of five Abbreviated New Drug Applications (ANDAs), marking a significant milestone in Senores' growth strategy across regulated pharmaceutical markets. Apnar Pharma, incorporated on December 12, 2014, is a privately held pharmaceutical company engaged in the licensing, development, a ...Read More >
Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Health ...Read More >
New Delhi, Jun 30 (PTI) Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement ...Read More >
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