(Adds details about issues raised by the FDA)
Dec 22 (Reuters) - Agile Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve the company's contraceptive patch due to deficiencies related to its quality adhesion test methods.
Shares of Agile, which also has other contraceptive patches in development, plunged 72 percent to $1.32 in premarket trading.
The health regulator said Agile would have to resolve the observations found during the inspection of its third-party manufacturing facility, Corium International Inc.
Agile's once-weekly, low-dose contraceptive patch, Twirla, is a combination hormonal patch that contains ethinyl estradiol and levonorgestrel.
The CRL did not identify any issues related to the safety of the drug, Agile said, adding that it intends to request a meeting with the FDA to address all the issues raised.
Agile said it had submitted an amendment to the regulator, addressing responses to concerns about the manufacturing facility and responded to issues related to quality adhesion test methods.
The so called complete response letter acknowledged the receipt of Agile's amendment and states that the amendment was not reviewed prior to the FDA's action, the company said.
However, the company said it could resubmit those responses to the FDA. (Reporting by Divya Grover in Bengaluru; Editing by Anil D'Silva)