Cipla gains post final USFDA approval for Pregabalin capsule

InvaGen Pharmaceuticals Inc, Cipla’s wholly-owned subsidiary has received final approval for its Abbreviated New Drug Application (ANDA) for Pregabalin Capsules.

The USFDA has given final approval for Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg which is AB-rated generic therapeutic equivalent version of Pfizer’s Lyrica.

Pregabalin capsules are indicated for management of neuropathic pain associated with diabetic peripheral neuropathy, management of postherpetic neuralgia, adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, management of fibromyalgia and management of neuropathic pain associated with spinal cord injury.

The IQVIA (IMS Health) data states that Lyrica had US sales of approximately US$5.4 billion for the 12-month period ending March 2019.

Cipla is a global pharmaceutical company which uses cutting-edge technology and innovation to meet the everyday needs of all patients.

The shares of the company on Monday opened at Rs. 532.90 against Friday’s close of Rs. 536.85. At 11:45 hours, it was trading at Rs. 538, 0.21 per cent higher than its previous close. The intraday high was Rs. 540 and intraday low was Rs. 525.85. Its 52-week high was Rs. 678 and 52-week low was Rs. 483.75 per share on the BSE.