- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Zydus Lifesciences US arm wins USFDA nod for Levothyroxine Sodium for Injection to treat myxedema coma
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.
Ahmedabad: Zydus Lifesciences Limited's U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has recently announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Levothyroxine Sodium for injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial. Levothyroxine Sodium injection manufactured by Fresenius Kabi USA, LLC.
Myxedema coma is an extreme or decompensated form of hypothyroidism and, while uncommon, is potentially lethal. Primary symptoms of the disease are low body temperature and altered mental status.
Levothyroxine Sodium injection is indicated for the treatment of myxedema coma.
Read also: Zydus Naftifine HCL 2% Cream Gets CDSCO Panel nod to treat superficial fungal infection of skin
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.
Levothyroxine Sodium injection had annual sales of USD 45.2 mn in the United States, according to IQVIA data (IQVIA MAT Sep 2022). The group now has 334 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.
Read also: Breast cancer test: Zydus Lifesciences to market OncoStem CanAssist Breast at affordable price
Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751