Cipla Limited said that it has secured final approval for its abbreviated new drug application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05% from the US Food and Drug Administration (FDA). Difluprednate Ophthalmic Emulsion 0.05% is a generic therapeutic equivalent version of Novartis Pharmaceutical’s Durezo. The drug is indicated in the US for the treatment of inflammation […]
Five Indian pharma companies – Cipla, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical Industries, and Torrent Pharmaceuticals will join forces to undertake a clinical trial of Molnupiravir, an investigational oral anti-viral drug for the treatment of mild Covid-19 in India. The clinical trial of Molnupiravir will be in an outpatient setting. Molnupiravir is being developed […]
Cipla’s step-down associate firm Avenue Therapeutics has failed to get approval from the US Food and Drug Administration (FDA) for IV tramadol as an alternative for reducing the use of conventional opioids in patients with acute pain. Avenue Therapeutics had been issued a second complete response letter (CRL) pertaining to its new drug application (NDA) […]
Cipla has entered into a non-exclusive licensing agreement with MSD (called Merck in the US and Canada) for the manufacturing and distribution of Molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral drug for the treatment of Covid-19 in patients who are not hospitalized. Molnupiravir is currently being assessed in a phase 3 trial. It is being developed […]
Cipla announced that its partner Stempeutics Research has secured regulatory approval from the Drug Controller General of India (DCGI) for the launch of Stempeucel, a cell therapy for the treatment of critical limb ischemia (CLI), in India. Stempeucel has been indicated for the treatment of the condition caused by Buerger’s Disease and Atherosclerotic Peripheral Arterial […]
Cipla has secured final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the US Food and Drug Administration (FDA) with a competitive generic therapy (CGT) designation. The Indian pharma company said that it is the first approved applicant for such CGT and as a result is eligible for […]