USFDA

Granules India, a Rs. 1,200 crore pharmaceutical major from Hyderabad, has received US FDA approval for ibuprofen tablets USP, 400 mg, 600 mg and 800 mg.

The US Food and Drug Administration (USFDA) has approved Aurobindo Pharma to market generic version of Prilosec delayed-release capsules used to treat ulcer.

The US Food and Drug Administration (FDA) has accepted leading global pharmaceutical company, Teva Pharmaceutical Industries Ltd's New Drug Application (NDA) for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). It is  a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in western countries, according to the World Health Organisation.

focus in the areas of pain management and addiction medicine, announced the approval by the US Food and Drug Administration (FDA) of a Supplemental New Drug Application (sNDA) for a new formulation of Onsolis (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. Onsolis is separately licensed by BDSI in Taiwan and South Korea.

Ajanta Pharma Limited, a Rs.1,450 crore plus Mumbai based specialty focused pharmaceutical formulation company, has received final approval from the United States Food and Drug Administration (FDA)  for its 3 Abbreviated New Drug Applications (ANDAs), montelukast tablets, 10mg,  montelukast sodium chewable tablets, 4mg & 5mg and montelukast oral granules.

ANI Pharmaceuticals, Inc., an integrated specialty pharmaceutical company, announced that its ANDA collaboration partner Sofgen,  received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nimodipine 30mg capsules. ANI and Sofgen expect to begin shipping to customers this year.

USFDA rejected Sun Pharma Advanced Research Company’s Application for its new anti-glaucoma eye drops. The product is to be manufactured at Sun Pharmaceutical Industries’ Halol facility. USFDA has indicated that a satisfactory resolution of the current good manufacturing practice (cGMP) deficiencies at this facility is a prerequisite for the final approval of Xelpros.

The U.S. Food and Drug Administration has banned drug imports from an India manufacturing unit of Emcure Pharmaceuticals Ltd over violations of standard manufacturing practices, the latest in a series of Indian firms to face such action.

The US Food and Drug Administration (FDA) has approved AstraZeneca's Iressa (gefitinib) tablets, 250mg once daily, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test.