Sun Pharma’s caffeine citrate (Cafcit) generic injectable approved in US

India’s Sun Pharma’s generic caffeine citrate injection has received approval from US FDA.

US FDA granted approval for Sun Pharma’s abbreviated new drug application (ANDA) for caffeine citrate intrvenous solution 30 mg/3 ml strength.

Sun Pharma caffeine citrate is the generic version of Mead Johnson’s Cafcit injection. In January 2008, Bedford Laboratories acquired Cafcit (caffeine citrate) injection and Cafcit oral solution from Mead Johnson & Company. Bedford Laboratories is now the reference listed drug holder.

In fact, Mead Johnson & Company – a subsidiary of Bristol-Myers Squibb Company- purchased the Cafcit (caffeine citrate) injection and oral suspension way back in 2003.

Cafcit was developed and marketed by OPR in close collaboration with Boehringer Ingelheim Pharmaceuticals, Inc., and its affiliate Roxane Laboratories, Inc.

Cafcit (caffeine citrate) is indicated for short term treatment of apnea in premature infants between 28 and <33 weeks gestational age.

Cafcit (caffeine citrate) is the only drug approved by US FDA for the short-term (10-12 days) treatment of apnea of prematurity in infants between 28 and less than 33 weeks gestational age.

Abraxis BioScience Inc received regulatory approval for the generic version of Mead Johnson and Co.’s Cafcit injection 60 mg/3 ml single-use vials in 2007.

USA’s APP Pharmaceuticals, a manufacturer of multi-source and branded injectable pharmaceutical products, has received approval from the Food and Drug Administration for its Abbreviated New Drug Application for caffeine citrate oral solution, USP, 20mg/ml, the equivalent of Bedford Laboratories’ Cafcit Oral Solution, last year.

According to 2007 IMS Health data, annualized US sales of caffeine citrate oral solution were approximately $12.6 million.

Abraxis Pharmaceutical Products will package the product in 60 mg/3 ml single-use vials and expects to commence marketing immediately, the biopharmaceutical company said in a statement.

Sun Pharma had in August 2009 received approval from US Food & Drug Administration (US FDA) for two abbreviated new drug applications (ANDAs) for oxaliplatin, a generic version of Eloxatin and sumatriptan, a generic version of Imitrex.

Sun Pharma will share the 180 days exclusivity for generic version of Eloxatin. The patent on Eloxatin is set to expire in calendar year 2013.

Oxaliplatin is used for treating colon and rectol cancer. It has an annual sale of approximately $2.3 billion in the US market. Sumatriptan is used for treating migraine.

Sun Pharmaceutical Industries Ltd is a speciality pharmaceutical company. In India, Sun is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics.

Israeli firm Taro Pharmaceuticals Industries Ltd filed a lawsuit against Sun Pharma alleging violations disclosure norms in the latter’s tender offer last month.

In its lawsuit filed in federal court in Manhattan, Taro alleged that Sun Pharmaceutical Industries Ltd., claiming the Indian drugmaker’s tender offer for Taro failed to disclose key information.

Sun Pharma didn’t include some key information about Food and Drug Administration violations by Sun’s U.S. generics affiliate Caraco Pharmaceutical Laboratories Inc. and the associated seizure of some of its products.

Sun Pharma own majority stake in U.S. subsidiary Caraco Pharmaceutical Laboratories Ltd. Recently, US FDA seized $20 million in products, in a follow-up action for manufacturing defects including oversized tablets at Caraco’s plants.

US FDA’s action could result in major impact of the events as harmful to Taro if Sun were to gain control of the company, Taro alleged.

Sun launched an open offer at a price of $7.75 per share in June last year through its subsidiary to acquire all shares of Taro, which was again legally challenged by the latter. The Supreme court has currently prohibited Sun Pharma from closing the offer until it gave a verdict on the issue.