USFDA

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.

The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Cleave Biosciences' lead drug candidate, CB-5083 for the treatment of multiple myeloma.

US Food and Drug Administration (FDA) has granted marketing authorisation for morphine sulfate ER tablets. A subsidiary of Zydus Pharmaceuticals (USA) Inc., Nesher has considerable expertise in niche therapies with development or products barriers, such as controlled release medications and DEA-controlled substances. Morphine sulfate ER tablets used in the treatment of chronic pain or cancer related pain. The product will be manufactured at Nesher Pharmaceuticals (USA) LLC, located at St. Louis, USA.

Jubilant Life Sciences has announced that it had received approval of the US Food and Drug Administration (FDA) for its tablets used in treating adults for various infections, including pneumonia. The market size for Levofloxacin is estimated to be $28 million (Rs.179 crore) per annum.

Zydus Cadila, a global pharmaceutical company, has received the final approval from the US Food and Drug Administration (FDA) to market pyridostigmine bromide tablets USP, 60 mg.  It is used for treating various neurological disorders.

The United States Food and Drug Administration has approved  Impax Specialty Pharma's  Zomig Nasal Spray for treatment of acute migraine with or without aura in pediatric patients who are 12 years and older.