Glenmark gets USFDA nod for oral contraceptive pills
- Manmohan Singh is India's "weakest PM": L K Advani
- 'Shahzada' and 'Matashree' are only concerned about being in power, says Modi; Sonia harps on secularism
- Supreme Court commutes death penalty of Devinderpal Singh Bhullar to life term
- Arun Jaitley rules out Modi's apology on 2002 Gujarat riots
- Elections 2014 LIVE: Manmohan Singh is India's "weakest PM", says Advani; Modi has 'deep flaws' in his character, says Chidambaram
Drug firm Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for its generic contraceptive norgestimate and ethinyl estradiol tablets.
Glenmark Generics Inc, a subsidiary of Glenmark Generics has been granted final approval for their abbreviated new drug application (ANDA) by the US Food and Drug Administration (USFDA) for Norgestimate and Ethinyl Estradiol tablets in the strengths of 0.25 mg/0.035 mg, Glenmark Pharmaceuticals said in a statement.
The tablets are generic version of Janssen Pharmaceuticals Inc oral contraceptive Ortho Cyclen tablets.
Citing IMS Health data for the 12-month period ending December 2011, the company said norgestimate and ethinyl estradiol tablets of strength 0.25 mg/0.035 mg garnered total market sales of approximately USD 88 million.
The company currently has 79 generic products authorised for distribution in the US market and 39 ANDA's pending approval with the USFDA, Glenmark said.
Today's approval is Glenmark's tenth female hormonal product authorised for distribution by the USFDA, it added.
Shares of Glenmark Pharmaceuticals were today trading at Rs 307.40 in the morning trade on BSE, down 0.47 per cent from its previous close.
- Modi has “deep flaws” in his character: Chidambaram
- Nigerian uprising kills 1,500 in 2014: Amnesty
- Sonakshi tweets to campaign for father Shatrughan
- Mamata attacks BJP, reiterates TMC will play vital role in govt formation
- AAP nominee against Khurshid quits, claims corruption in party
- MP: Sushma Swaraj, Kamal Nath, Jyotiraditya Scindia among heavyweights in LS poll ring