Notice: Constant automattic\jetpack\extensions\social_previews\FEATURE_NAME already defined in /home2/theprkho/public_html/thepharmatimes.in/wp-content/plugins/jetpack/extensions/blocks/social-previews/social-previews.php on line 14
Aurobindo Pharma gets USFDA nod to sell antibiotic oral suspension - The Pharma Times | Pharma & Health Care News Portal
Categories: Drug Research

Aurobindo Pharma gets USFDA nod to sell antibiotic oral suspension

New Delhi, April 16, 2015 : Aurobindo PharmaBSE 4.01 % today said it has got final approval from the US Food and Drug Administration (USFDA) to make and sell its generic version of oral suspension of antibiotic Cefixime.

The approval by the USFDA is for strengths of 100 mg/5 ml and 200 mg/5 ml and the product is ready for launch, Aurobindo Pharma said in a statement.
The approved solutions are bio-equivalent and therapeutically equivalent to the reference listed drug product Suprax Oral Suspension USP 100 mg/5 mL and 200 mg/5 mL, respectively of Lupin Pharmaceuticals Inc, it added.
Citing IMS data, the company said the product has an estimated market size of USD 123 million for the twelve months ended February 2015.
Cefixime for oral suspension is indicated for treatment of adults and pediatric patients of six months of age or older, in urinary tract infections, acute exacerbations of chronic bronchitis, uncomplicated gonorrhea, pharyngitis and tonsillitis, among others, it added.
Aurobindo now has 11 abbreviated new drug applications approved out of Unit VI formulation facility in Hyderabad, India, it said.
Aurobindo Pharma shares were trading 1.60 per cent up at Rs 1,372.40 per scrip during afternoon session on the BSE. PTI
The Pharma Times News Bureau

Share
Published by
The Pharma Times News Bureau
9 years ago

Recent Posts

Fortis Hospital, Bannerghatta Road Launches dedicated Parkinson’s Disease and Deep Brain Stimulation Clinic

-  This specialized division empowers patients with neurological disorders to reclaim their mobility through a…

2 days ago

Milestone set in Indian Medical History – SSI Mantra Surgical Robotic System Performs the First-Ever Successful Surgery on One-Year-Old Infant

SSI Mantra Robotic System performs a successful urology procedure on a one-year-old infant with a…

4 days ago

Manipal Hospital Ghaziabad organises Fire Safety Training to Enhance Emergency Response

Ghaziabad, April 22, 2024: In order to strengthen the safety and wellbeing of people, Manipal Hospital…

2 weeks ago

Professor Dr Robert Zeiser receives DKMS Mechtild Harf Science Award 2024

DKMS EMPHASIZES ITS COMMITMENT TO BLOOD CANCER RESEARCH, SUPPORTS YOUNG SCIENTISTS, AND RECOGNIZES OUTSTANDING RESEARCH…

2 weeks ago

Dr. Reddy’s launches drug-free migraine management device Nerivio® in Europe following successful launch in India

Dr. Reddy's has launched Nerivio® in Germany through its step-down subsidiary betapharm To be followed…

3 weeks ago

Ankura Hospital Doctors perform a successful Complex Lung Surgery on a 4-month-old Infant

 Hyderabad, April 13, 2024: Ankura Hospital for Women and Children is proud to announce a remarkable medical…

3 weeks ago