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FDA gives the greenlight to Sunpharma for an Upgraded Docetaxel (DoceFrez)

Sun Pharma (NSE: SUNPHARMA) received FDA approval for a re-formulation that yielded a stronger strength of Docefrez. . An anti-neoplastic agent that carries anti-tumor activity against tumors. Docefrez receives an improvement of 2.0 mg/0.8 mL for its 20 mg strength and 24 mg/mL for the 80 mg strength, benefiting patients who may need a higher concentration yield to treat their tumors.

DOCETAXEL is an active ingredient found in Docefrez, which is no stranger to Sun Pharma. The drug has been previously  approved in 1996 with the active ingredient of Docetaxel. Sun Pharma received approval to treat Breast Cancer, Non-small Lung Cancer (NSCLC), and Hormone Refractory Prostate Cancer (HRPC).  By building on a previous submission, Sun Pharma had to include data that shows efficacy for Docefrez with a higher yield. The FDA reviewed 505(b)(2) NDA for DOCEFREZ (docetaxel) on November third of  2010 but didn’t grant Sun Pharma until this year.

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